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Trials Directory

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Showing 92 trials.

Trials found: 92 / 92

8002

(Supported trial)

STATUS: Archive

System 8002 Trial: Computerised cardiotocographic interpretation of the compromised fetus during the antenatal period.

Trial started: 1998  Trial ended: 2002

NPEU role: Assisting with design of trial and data collection tools. Writing data entry program and advising on data management. Analysis of data and report writing.

Acyclovir

STATUS: Archive

A randomised placebo controlled trial of suppressive acyclovir in late pregnancy in women with recurrent genital herpes infection.

Trial started: 1990  Trial ended: 1995

Show Publications
  • Brocklehurst P, Kinghorn G, Carney O, Helsen K, Ross E, Ellis E, Shen R, Cowan F, Mindel A. A randomised placebo controlled trial of suppressive acyclovir in late pregnancy in women with recurrent genital herpes infection. Br J Obstet Gynaecol. 1998;105(3):275-80.
    http://www.ncbi.nlm.nih.gov/pubmed/9532986
  • Brocklehurst P, Roberts T. Should acyclovir prophylaxis be used in late pregnancy in women with recurrent genital herpes infection? How to use a clinical decision analysis. Genitourin Med. 1997;73(4):314-9.
    http://www.ncbi.nlm.nih.gov/pubmed/9389959

ADEPT

STATUS: Archive

Abnormal Doppler Enteral Prescription Trial.

Trial started: 2006  Trial ended: 2009

Show Publications
  • Partlett C, Hall NJ, Leaf A, Juszczak E, Linsell L. Application of the matched nested case-control design to the secondary analysis of trial data. BMC Med Res Methodol. 2020;20(1):117.
    https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-020-01007-w
  • Juszczak E, Partlett C, Leaf A, Linsell L, Hall N. Timing of nutritional exposures in relation to the development of severe necrotising enterocolitis (NEC) in preterm growth restricted infants. Presented at the Neonatal Society 2018 Spring Meeting; 30 March 2018; Royal Society of Medicine, London.
    http://www.neonatalsociety.ac.uk/abstracts/juszczake_2018_nutritionnec.shtml
  • Kempley S, Gupta N, Linsell L, Dorling J, McCormick K, Mannix P, Juszczak E, Brocklehurst P, Leaf A. Feeding infants below 29 weeks' gestation with abnormal antenatal Doppler: analysis from a randomised trial. Arch Dis Child Fetal Neonatal Ed. 2014;99(1):F6-f11.
    http://www.ncbi.nlm.nih.gov/pubmed/23973795
  • Leaf A, Dorling J, Kempley S, McCormick K, Mannix P, Linsell L, Juszczak E, Brocklehurst P. Early or delayed enteral feeding for preterm growth-restricted infants: a randomized trial. Pediatrics. 2012;129(5):e1260-8.
    http://www.ncbi.nlm.nih.gov/pubmed/22492770
Published Protocol
  • Leaf A, Dorling J, Kempley S, McCormick K, Mannix P, Brocklehurst P. ADEPT - Abnormal Doppler Enteral Prescription Trial (Study Protocol). BMC Pediatrics. 2009;9(63):11.
    http://www.biomedcentral.com/1471-2431/9/63

Admission cardiotocography

(Supported trial)

STATUS: Archive

Admission cardiotocography: a randomised controlled trial.

Trial started: 1997  Trial ended: 2001

NPEU role: Randomisation, analysis of results and co-writing of report.

Show Publications

ALPS

STATUS: Archive

Alternative Labour Pain management Study (pilot study).

Trial started: 2004  Trial ended: 2006

Show Publications
  • Kimber L, McNabb M, Mc Court C, Haines A, Brocklehurst P. Massage or music for pain relief in labour: a pilot randomised placebo controlled trial. Eur J Pain. 2008;12(8):961-9.
    http://www.ncbi.nlm.nih.gov/pubmed/18304848

ANODE

STATUS: Archive

ANODE: prophylactic ANtibiotics for the prevention of infection following Operative DElivery

Trial started: 2015  Trial ended: 2018

Show Publications
  • Knight M, Chiocchia V, Partlett C, Rivero-Arias O, Hua X, Bowler U, Gray J, Gray S, Hinshaw K, Khunda A, Moore P, Mottram L, Owino N, Pasupathy D, Sanders J, Sultan AH, Thakar R, Tuffnell D, Linsell L, Juszczak E. Intravenous co-amoxiclav to prevent infection after operative vaginal delivery: the ANODE RCT. Health Technol Assess. 2019;23(54):1-54.
    https://doi.org/10.3310/hta23540
  • Knight M, Chiocchia V, Partlett C, Rivero-Arias O, Hua X, Hinshaw K, et al. Prophylactic antibiotics in the prevention of infection after operative vaginal delivery (ANODE): a multicentre randomised controlled trial. The Lancet. 2019;393(10189):2395-403.
    http://dx.doi.org/10.1016/ S0140-6736(19)30773-1
  • Mohamed-Ahmed O, Hinshaw K, Knight M. Operative vaginal delivery and post-partum infection. Best Pract Res Clin Obstet Gynaecol. 2019;56:93-106.
    https://doi.org/10.1016/j.bpobgyn.2018.09.005
Published Protocol
  • Knight M, Mottram L, Gray S, Partlett C, Juszczak E. Prophylactic antibiotics for the prevention of infection following operative vaginal delivery (ANODE): study protocol for a randomised controlled trial. Trials. 2018;19(1):395.
    https://doi.org/10.1186/s13063-018-2787-0

APPLE

STATUS: Archive

APPLE (Pilot study) Assessment of the Prevention of Pulmonary embolism and deep venous thromboses with Low molecular weight hEparin.

Trial started: 1998  Trial ended: 2001

Show Publications
  • Gates S, Brocklehurst P, Ayers S, Bowler U, on behalf of the Thromboprophylaxis in Pregnancy Advisory Group. Thromboprophylaxis and pregnancy: two randomized controlled pilot trials that used low-molecular-weight heparin. Am J Obstet Gynecol. 2004;191(4):1296-303.
    http://www.ncbi.nlm.nih.gov/pubmed/15507957

(Supported trial)

STATUS: Analysis-and-dissemination

Antiseptic Randomised Controlled Trial for Insertion of Catheters: The efficacy and safety of two topical antiseptic solutions for skin disinfection prior to percutaneous central venous catheter insertion in preterm neonates: a feasibility study

Trial started: 2015  Trial ended: 2019

NPEU role: Input into trial design and oversight (advice on randomisation, database development/management, regulatory functions and statistical analysis), data analysis. Study led by Norfolk and Norwich University Hospitals NHS Foundation Trust.

Show Publications Published Protocol
  • Clarke P, Craig JV, Wain J, Tremlett C, Linsell L, Bowler U, et al. Safety and efficacy of 2% chlorhexidine gluconate aqueous versus 2% chlorhexidine gluconate in 70% isopropyl alcohol for skin disinfection prior to percutaneous central venous catheter insertion in preterm neonates: the ARCTIC randomised-controlled feasibility trial protocol. BMJ open. 2019;9(2):e028022
    http://dx.doi.org/10.1136/bmjopen-2018-028022

STATUS: Follow-up

Outcome after Selective Early Closure of Ductus Arteriosus in Extremely Preterm Babies

Trial started: 2014  Trial ended: 2021

Show Publications
  • Bell JL, Gupta S, Juszczak E, Hardy P, Linsell L. Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies-a statistical analysis plan for short-term outcomes. Trials. 2021;22(1):368.
    https://doi.org/10.1186/s13063-021-05324-3
Published Protocol
  • Gupta S, Juszczak E, Hardy P, Subhedar N, Wyllie J, Kelsall W, et al. Study protocol: baby-OSCAR trial: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies, a multicentre, masked, randomised placebo-controlled parallel group trial. BMC Pediatr. 2021;21(1):100.
    https://doi.org/10.1186/s12887-021-02558-7

BLASP

STATUS: Archive

BLASP Barbados Low-dose Aspirin Study in Pregnancy (A randomised controlled trial of low-dose aspirin for the prevention of pre-eclampsia and intrauterine growth retardation and for the reduction of perinatal mortality among barbadian women).

Trial started: 1992  Trial ended: 1994

Show Publications
  • Rotchell YE, Cruickshank JK, Gay MP, Griffiths J, Stewart A, Farrell B, Ayers S, Hennis A, Grant A, Duley L, Collins R. Barbados Low Dose Aspirin Study in Pregnancy (BLASP): a randomised trial for the prevention of pre-eclampsia and its complications. Br J Obstet Gynaecol. 1998;105(3):286-92.
    http://www.ncbi.nlm.nih.gov/pubmed/9532988

BOOST-II UK

STATUS: Archive

Which oxygen saturation level should we use for very premature infants? A randomised controlled trial.

Trial started: 2007  Trial ended: 2014

Show Publications
  • Askie LM, Darlow BA, Finer N, Schmidt B, Stenson B, Tarnow-Mordi W, et al. Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA. 2018;319(21):2190-201.
    http://dx.doi.org/10.1001/jama.2018.5725
  • Fleck BW, Williams C, Juszczak E, Cocker K, Stenson BJ, Darlow BA, et al. An international comparison of retinopathy of prematurity grading performance within the Benefits of Oxygen Saturation Targeting II trials. Eye. 2017;32:74.
    http://dx.doi.org/10.1038/eye.2017.150
  • Tarnow-Mordi W, Stenson B, Kirby A, Juszczak E, Donoghoe M, Deshpande S, et al. Outcomes of Two Trials of Oxygen-Saturation Targets in Preterm Infants. N Engl J Med. 2016;374(8):749-60.
    http://dx.doi.org/10.1056/NEJMoa1514212
  • Moreton RB, Fleck BW, Fielder AR, Williams CA, Butler L, Wilson C, et al. The effect of oxygen saturation targeting on retinal blood vessel growth using retinal image data from the BOOST-II UK Trial. Eye (London, England). 2016;30(4):577-81.
    http://dx.doi.org/10.1038/eye.2015.280
  • The BOOST II United Kingdom Australia and New Zealand Collaborative Groups. Oxygen saturation and outcomes in preterm infants. N Engl J Med. 2013;368(22):2094-104.
    http://dx.doi.org/10.1056/NEJMoa1302298
  • Stenson B, Brocklehurst P, Tarnow-Mordi W. Increased 36-week survival with high oxygen saturation target in extremely preterm infants. N Engl J Med. 2011;364(17):1680-2.
    http://dx.doi.org/10.1056/NEJMc1101319
  • Johnston ED, Boyle B, Juszczak E, King A, Brocklehurst P, Stenson BJ. Oxygen targeting in preterm infants using the Masimo SET Radical pulse oximeter. Arch Dis Child Fetal Neonatal Ed. 2011;96(6):F429-33.
    http://dx.doi.org/10.1136/adc.2010.206011
Published Protocol
  • Askie LM, Brocklehurst P, Darlow BA, Finer N, Schmidt B, Tarnow-Mordi W. NeOProM: Neonatal Oxygenation Prospective Meta-analysis Collaboration study protocol. BMC Pediatr.11:6.
    http://www.biomedcentral.com/1471-2431/11/6

Bristol Third Stage Trial

STATUS: Archive

Bristol third stage management trial.

Trial started: 1986  Trial ended: 1987

Show Publications
  • Prendiville WJ, Harding JE, Elbourne DR, Stirrat GM. The Bristol third stage trial: active versus physiological management of third stage of labour. BMJ. 1988;297(6659):1295-300.
    http://www.ncbi.nlm.nih.gov/pubmed/3144366
  • Harding JE, Elbourne DR, Prendiville WJ. Views of mothers and midwives participating in the Bristol randomized, controlled trial of active management of the third stage of labor. Birth. 1989;16(1):1-6.
    http://www.ncbi.nlm.nih.gov/pubmed/2662981

BUMPES

(Supported trial)

STATUS: Archive

Upright maternal position in second stage labour in women with epidural analgesia; a randomised controlled trial.

Trial started: 2010  Trial ended: 2013

NPEU role: Randomisation service, statistical analysis and economic evaluation. Trial website: https://www.birmingham.ac.uk/research/bctu/trials/womens/bumpes/bumpes-trial.aspx

Show Publications
  • The Epidural and Position Trial Collaborative Group. Upright versus lying down position in second stage of labour in nulliparous women with low dose epidural: BUMPES randomised controlled trial. BMJ. 2017;359.
    http://dx.doi.org/10.1136/bmj.j4471

CAESAR

STATUS: Archive

Trial of Caesarean Section Surgical Techniques.

Trial started: 2000  Trial ended: 2006

Show Publications

Cervical Cerclage Trial (CCT) main trial

STATUS: Archive

MRC/RCOG Cervical Cerclage Trial.

Trial started: 1981  Trial ended: 1988

Show Publications
  • MRC/RCOG Working Party on Cervical Cerclage. Final report of the Medical Research Council/Royal College of Obstetricians and Gynaecologists multicentre randomised trial of cervical cerclage. Br J Obstet Gynaecol. 1993;100(6):516-23.
    http://www.ncbi.nlm.nih.gov/pubmed/8334085

CLASP

(Supported trial)

STATUS: Archive

CLASP (Collaborative Low-dose Aspirin Study in Pregnancy): a randomised trial of low-dose aspirin for the prevention and treatment of pre-eclampsia.

Trial started: 1988  Trial ended: 1994

NPEU role: Support in co-ordinating trial.

Show Publications
  • The CLASP Collaborative Group. CLASP: a randomised trial of low-dose aspirin for the prevention and treatment of pre-eclampsia among 9364 pregnant women. CLASP (Collaborative Low-dose Aspirin Study in Pregnancy) Collaborative Group. Lancet. 1994;343(8898):619-29.
    http://www.ncbi.nlm.nih.gov/pubmed/7906809

Collaborative Eclampsia Trial

STATUS: Archive

Magnesium sulphate and diazepam in the management of eclampsia: a randomised controlled trial OR Anticonvulsant management of eclampsia.

Trial started: 1991  Trial ended: 1994

Show Publications
  • The Eclampsia Trial Collaborative Group. Which anticonvulsant for women with eclampsia? Evidence from the Collaborative Eclampsia Trial. Lancet. 1995;345(8963):1455-63.
    http://www.ncbi.nlm.nih.gov/pubmed/7769899

CORONIS

STATUS: Archive

Prevention of maternal morbidity after caesarean section in developing countries: a factorial RCT of surgical methods.

Trial started: 2007  Trial ended: 2011

Show Publications
  • CORONIS Collaborative Group, Abalos E, Addo V, Brocklehurst P, El Sheikh M, Farrell B, Gray S, Hardy P, Juszczak E, Mathews JE, Masood SN, Oyarzun E, Oyieke J, Sharma JB, Spark P. Caesarean section surgical techniques (CORONIS): a fractional, factorial, unmasked, randomised controlled trial. Lancet. 2013;382(9888):234-48.
    http://www.ncbi.nlm.nih.gov/pubmed/23721753
Published Protocol
  • Brocklehurst P, on behalf of the CORONIS Trial Collaborative Group. The CORONIS Trial: International study of caesarean section surgical techniques: a randomised fractional, factorial trial. BMC Pregnancy and Childbirth. [Protocol] 2007:7-24.
    http://www.biomedcentral.com/1471-2393/7/24

CORONIS Long Term Follow-up

STATUS: Archive

Maternal morbidity after caesarean section in developing countries: long term follow-up of a large factorial trial.

Trial started: 2011  Trial ended: 2015

Show Publications
  • Abalos E, Addo V, Brocklehurst P, El Sheikh M, Farrell B, Gray S, et al. Caesarean section surgical techniques: 3 year follow-up of the CORONIS fractional, factorial, unmasked, randomised controlled trial. Lancet. 2016;388(10039):62-72.
    https://doi.org/10.1016/S0140-6736(16)00204-X

CVS

STATUS: Archive

MRC Randomised trial to compare first trimester chorion villus sampling with second trimester amniocentesis for fetal diagnosis OR MRC European collaborative trial to assess the safety of chorion villus sampling for fetal diagnosis.

Trial started: 1985  Trial ended: 1990

Show Publications

Dexamethasone main trial and follow-up at 3 years and at 13-17 years

STATUS: Archive

Collaborative randomised controlled trial of dexamethasone in neonatal chronic lung disease.

Trial started: 1984  Trial ended: 1992

Show Publications
  • Jones RA. Randomized, controlled trial of dexamethasone in neonatal chronic lung disease: 13- to 17-year follow-up study: II. Respiratory status, growth, and blood pressure. Pediatrics. 2005;116(2):379-84.
    http://www.ncbi.nlm.nih.gov/pubmed/16061592
  • Jones RA. Randomized, controlled trial of dexamethasone in neonatal chronic lung disease: 13- to 17-year follow-up study: I. Neurologic, psychological, and educational outcomes. Pediatrics. 2005;116(2):370-8.
    http://www.ncbi.nlm.nih.gov/pubmed/16061591
  • Jones R, Wincott E, Elbourne D, Grant A. Controlled trial of dexamethasone in neonatal chronic lung disease: a 3-year follow-up. Pediatrics. 1995;96(5 Pt 1):897-906.
    http://www.ncbi.nlm.nih.gov/pubmed/7478833
  • Collaborative Dexamethasone Trial Group. Dexamethasone therapy in neonatal chronic lung disease: an international placebo-controlled trial. Pediatrics. 1991;88(3):421-7.
    http://www.ncbi.nlm.nih.gov/pubmed/1881718

STATUS: Recruiting

Developmental Outcome of Long-Term Feed Supplementation in Neonates - The DOLFIN randomised controlled trial

Trial started: 2021  Trial ended: 2027

Dublin Birthing Chair Trial

STATUS: Archive

The Coombe Lying-In Hospital Birthing Chair Trial.

Trial started: 1984  Trial ended: 1985

Show Publications
  • Crowley P, Elbourne D, Ashurst H, Garcia J, Murphy D, Duignan N. Delivery in an obstetric birth chair: a randomized controlled trial. Br J Obstet Gynaecol. 1991;98(7):667-74.
    http://www.ncbi.nlm.nih.gov/pubmed/1883790

Dublin Fetal Heart Rate Monitoring Trial

STATUS: Archive

The Dublin randomised controlled trial of intrapartum fetal heart rate monitoring.

Trial started: 1981  Trial ended: 1985

Show Publications
  • Grant A, O'Brien N, Joy MT, Hennessy E, MacDonald D. Cerebral palsy among children born during the Dublin randomised trial of intrapartum monitoring. Lancet. 1989;2(8674):1233-6.
    http://www.ncbi.nlm.nih.gov/pubmed/2573757
  • MacDonald D, Grant A, Sheridan-Pereira M, Boylan P, Chalmers I. The Dublin randomized controlled trial of intrapartum fetal heart rate monitoring. Am J Obstet Gynecol. 1985;152(5):524-39.
    http://www.ncbi.nlm.nih.gov/pubmed/3893132

STATUS: Analysis-and-dissemination

Freezing of embryos in assisted conception: a randomised controlled trial evaluating the clinical and cost-effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer, compared with a policy of fresh embryo transfer in women undergoing in vitro fertilisation.

Trial started: 2015  Trial ended: 2019

Show Publications
  • Maheshwari A, Bell JL, Bhide P, Brison D, Child T, Chong HY, et al. Elective freezing of embryos versus fresh embryo transfer in IVF: a multicentre randomized controlled trial in the UK (E-Freeze). Hum Reprod. 2022;37(3):476-87.
    https://doi.org/10.1093/humrep/deab279
  • Maheshwari A, Bari V, Bell JL, Bhattacharya S, Bhide P, Bowler U, Brison D, Child T, Chong HY, Cheong Y, Cole C, Coomarasamy A, Cutting R, Goodgame F, Hardy P, Hamoda H, Juszczak E, Khalaf Y, King A, Kurinczuk JJ, Lavery S, Lewis-Jones C, Linsell L, Macklon N, Mathur R, Murray D, Pundir J, Raine-Fenning N, Rajkohwa M, Robinson L, Scotland G, Stanbury K, Troup S. Transfer of thawed frozen embryo versus fresh embryo to improve the healthy baby rate in women undergoing IVF: the E-Freeze RCT. Health Technol Assess. 2022;26(25):1-142.
    https://www.journalslibrary.nihr.ac.uk/hta/AEFU1104/#/abstract
  • Bell JL, Hardy P, Greenland M, Juszczak E, Cole C, Maheshwari A, Bhattacharya S, Linsell L. E-Freeze - a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation: a statistical analysis plan. Trials. 2020;21(1):596.
    https://doi.org/10.1186/s13063-020-04441-9
Published Protocol
  • Maheshwari A, Bhattacharya S, Bowler U, Brison D, Child T, Cole C, et al. Study protocol: E-freeze - freezing of embryos in assisted conception: a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation. Reprod Health. 2019;16(1):81. DOI: 10.1186/s12978-019-0737-2

EC Concerted Action Programme: Ethamyslate Trial main trial and follow-up

STATUS: Archive

The EC randomised controlled trial of prophylactic ethamyslate for very preterm neonates: early mortality and morbidity.

Trial started: 1990  Trial ended: 1991

Show Publications
  • Elbourne D, Ayers S, Dellagrammaticas H, Johnson A, Leloup M, Lenoir-Piat S. Randomised controlled trial of prophylactic ethamsylate: follow up at 2 years of age. Arch Dis Child Fetal Neonatal Ed. 2001;84(3):F183-7.
    http://www.ncbi.nlm.nih.gov/pubmed/11320045
  • The EC Ethamsylate Trial Group. The EC randomised controlled trial of prophylactic ethamsylate for very preterm neonates: early mortality and morbidity. Arch Dis Child Fetal Neonatal Ed. 1994;70(3):F201-5.
    http://www.ncbi.nlm.nih.gov/pubmed/8198414

EC Concerted Action Programme: Volume Expansion Trial

(Supported trial)

STATUS: Archive

Multicentre trial of prophylactic volume expansion for very preterm neonates.

Trial started: 1990  Trial ended: 1992

NPEU role: Co-supervision of randomisation and study conduct.

Show Publications
  • Northern Neonatal Nursing Initiative Trial Group. A randomized trial comparing the effect of prophylactic intravenous fresh frozen plasma, gelatin or glucose on early mortality and morbidity in preterm babies. The Northern Neonatal Nursing Initiative [NNNI] Trial Group. Eur J Pediatr. 1996;155(7):580-8.
    http://www.ncbi.nlm.nih.gov/pubmed/8831082
  • Northern Neonatal Nursing Initiative Trial Group. Randomised trial of prophylactic early fresh-frozen plasma or gelatin or glucose in preterm babies: outcome at 2 years. Lancet. 1996;348(9022):229-32.
    http://www.ncbi.nlm.nih.gov/pubmed/8684200

ECMO and follow up

STATUS: Archive

The Collaborative ECMO Trial. A multicentre randomised controlled trial of neonatal extra-corporeal membrane oxygenation.

Trial started: 1993  Trial ended: 1995

Show Publications
  • McNally H, Bennett CC, Elbourne D, Field DJ. United Kingdom collaborative randomized trial of neonatal extracorporeal membrane oxygenation: follow-up to age 7 years. Pediatrics. 2006;117(5):e845-54.
    http://www.ncbi.nlm.nih.gov/pubmed/8676720
  • Petrou S, Edwards L. Cost effectiveness analysis of neonatal extracorporeal membrane oxygenation based on four year results from the UK Collaborative ECMO Trial. Arch Dis Child Fetal Neonatal Ed. 2004;89(3):F263-8.
    http://www.ncbi.nlm.nih.gov/pubmed/9756807
  • Bennett CC, Johnson A, Field DJ, Elbourne D. UK collaborative randomised trial of neonatal extracorporeal membrane oxygenation: follow-up to age 4 years. Lancet. 2001;357(9262):1094-6.
    http://www.ncbi.nlm.nih.gov/pubmed/11297963
  • The UK Collaborative ECMO Trial Group. UK collaborative randomised trial of neonatal extracorporeal membrane oxygenation. Lancet. 1996;348(9020):75-82.
    http://www.ncbi.nlm.nih.gov/pubmed/16636114

ELFIN

STATUS: Archive

A multi-centre randomised placebo-controlled trial of prophylactic enteral supplementation with bovine lactoferrin to prevent late-onset invasive infection in very preterm or very low birth weight infants.

Trial started: 2013  Trial ended: 2017

Show Publications
  • Griffiths J, Jenkins P, Vargova M, Bowler U, Juszczak E, King A, et al. Enteral lactoferrin supplementation for very preterm infants: a randomised placebo-controlled trial. The Lancet. 2019;393(10170):423-33.
    http://dx.doi.org/10.1016/ S0140-6736(18)32221-9
  • Griffiths J, Jenkins P, Vargova M, Bowler U, Juszczak E, King A, Linsell L, Murray D, Partlett C, Patel M, Berrington J, Embleton N, Dorling J, Heath PT, McGuire W, Oddie S. Enteral lactoferrin to prevent infection for very preterm infants: the ELFIN RCT. Health Technol Assess. 2018;22(74):1-60.
    https://doi.org/10.3310/hta22740
  • The ELFIN Trial Investigators Group. Lactoferrin immunoprophylaxis for very preterm infants. Arch Dis Child Fetal Neonatal Ed. 2013;98(1):F2-4.
    http://www.ncbi.nlm.nih.gov/pubmed/22894857
Published Protocol
  • The ELFIN Trial Investigators Group. Summary Protocol for a Multi-Centre Randomised Controlled Trial of Enteral Lactoferrin Supplementation in Newborn Very Preterm Infants (ELFIN). Neonatology. 2018;114(2):142-8.
    https://doi.org/10.1159/000488927

ELSA

(Supported trial)

STATUS: Archive

The Early Labour Support and Assessment trial.

Trial started: 2004  Trial ended: 2008

NPEU role: Trial design, randomisation, statistical analysis and report writing carried out by NPEU. The study was led by the Mother and Infant Research Unit (MIRU), University of York.

ePrime (MRI)

(Supported trial)

STATUS: Analysis-and-dissemination

Evaluation of MR Imaging to predict neurodevelopmental impairment to preterm infants.

Trial started: 2010  Trial ended: 2015

NPEU role: Qualitative research, randomisation service, clinical database, statistical analysis and economic evaluation. Study led by Imperial College, London .

Show Publications
  • Edwards AD, Redshaw ME, Kennea N, Rivero-Arias O, Gonzales-Cinca N, Nongena P, et al. Effect of MRI on preterm infants and their families: a randomised trial with nested diagnostic and economic evaluation. Arch Dis Child Fetal Neonatal Ed. 2018;103(1):F15-f21.
    http://dx.doi.org/10.1136/archdischild-2017-313102

EUPHRATES

(Supported trial)

STATUS: Archive

EUPHRATES trial of blood collector bag in third stage of labour.

Trial started: 2006  Trial ended: 2008

NPEU role: Advised and approved analysis plan. Checked analysis, contributed to paper.

Show Publications
  • Zhang WH, Deneux-Tharaux C, Brocklehurst P, Juszczak E, Joslin M, Alexander S. Effect of a collector bag for measurement of postpartum blood loss after vaginal delivery: cluster randomised trial in 13 European countries. BMJ. 2010;340:c293.
    http://www.ncbi.nlm.nih.gov/pubmed/20123835

STATUS: Follow-up

EXpressing in PREmaturity – Simple interventionS: Does a guided relaxation audio track increase yield of expressed milk in mothers of very preterm infants? A randomised controlled trial and nested exploratory work

Trial started: 2021  Trial ended: 2023

Show Publications
  • Levene I, Alderdice F, McCleverty B, O’Brien F, Fewtrell M, Quigley MA. A report on parent involvement in planning a randomised controlled trial in neonatology and lactation – insights for current and future research. International Breastfeeding Journal. 2022;17(1):69.
    https://doi.org/10.1186/s13006-022-00509-1
Published Protocol
  • Levene I, Bell JL, Cole C, Stanbury K, O’Brien F, Fewtrell M, et al. Comparing the effect of a lactation-specific relaxation and visualisation intervention versus standard care on lactation and mental health outcomes in mothers of very premature infants (the EXPRESS trial): study protocol for a multi-centre, unmasked, randomised, parallel-group trial. Trials. 2022;23(1):611.
    https://doi.org/10.1186/s13063-022-06570-9

Fetal Movements Trial

STATUS: Archive

Randomised trial of fetal movement counting.

Trial started: 1985  Trial ended: 1988

Show Publications
  • Grant A, Elbourne D, Valentin L, Alexander S. Routine formal fetal movement counting and risk of antepartum late death in normally formed singletons. Lancet. 1989;2(8659):345-9.
    http://www.ncbi.nlm.nih.gov/pubmed/2569550

Fish oil supplementation and pregnancy duration

(Supported trial)

STATUS: Archive

Trial started: 1989  Trial ended: 1990

NPEU role: Advisory.

Show Publications
  • Olsen SF, Sorensen JD, Secher NJ, Hedegaard M, Henriksen TB, Hansen HS, Grant A. Randomised controlled trial of effect of fish-oil supplementation on pregnancy duration. Lancet. 1992;339(8800):1003-7.
    http://www.ncbi.nlm.nih.gov/pubmed/1349049

STATUS: Analysis-and-dissemination

A randomised controlled trial of FRenotomy and breastfeeding support Or breastfeeding Support without frenotomy to investigate continuation of breastfeeding for babies with Tongue-TIE

Trial started: 2018  Trial ended: 2021

GRACES

(Supported trial)

STATUS: Archive

Glibenclamide and metfoRmin versus stAndard Care in gEstational diabeteS (GRACES) – a feasibility open label randomised trial

Trial started: 2014  Trial ended: 2016

NPEU role: Randomisation service, database and statistical analysis. Trial is run by the University of Edinburgh. https://www.npeu.ox.ac.uk/graces

Show Publications
  • Reynolds RM, Denison FC, Juszczak E, Bell JL, Penneycard J, Strachan MWJ, et al. Glibenclamide and metfoRmin versus stAndard care in gEstational diabeteS (GRACES): a feasibility open label randomised trial. BMC Pregnancy Childbirth. 2017;17(1):316.
    https://doi.org/10.1186/s12884-017-1505-3

Hinchingbrooke Trial

(Supported trial)

STATUS: Archive

The Hinchinbrooke Third Stage Randomised Controlled Trial.

Trial started: 1993  Trial ended: 1995

NPEU role: Data processing and analysis undertaken by NPEU. Collaboration with Hinchingbrooke Healthcare Trust.

Show Publications
  • Rogers J, Wood J, McCandlish R, Ayers S, Truesdale A, Elbourne D. Active versus expectant management of third stage of labour: the Hinchingbrooke randomised controlled trial. Lancet. 1998;351(9104):693-9.
    http://www.ncbi.nlm.nih.gov/pubmed/9504513

Hip Trial

STATUS: Archive

Ultrasound imaging in the management of clinical neonatal hip instability. The Hip Trial: a randomised controlled trial.

Trial started: 1994  Trial ended: 1998

Show Publications
  • Gardner F, Dezateux C, Elbourne D, Gray A, King A, Quinn A. The hip trial: psychosocial consequences for mothers of using ultrasound to manage infants with developmental hip dysplasia. Arch Dis Child Fetal Neonatal Ed. 2005;90(1):F17-24.
    http://www.ncbi.nlm.nih.gov/pubmed/15613565
  • Elbourne D, Dezateux C, Arthur R, Clarke NM, Gray A, King A, Quinn A, Gardner F, Russell G. Ultrasonography in the diagnosis and management of developmental hip dysplasia (UK Hip Trial): clinical and economic results of a multicentre randomised controlled trial. Lancet. 2002;360(9350):2009-17.
    http://www.ncbi.nlm.nih.gov/pubmed/12504396

HOOP Trial

STATUS: Archive

The HOOP Study: Hands on or poised.

Trial started: 1994  Trial ended: 1996

Show Publications

I2S2

STATUS: Archive

A randomised controlled trial of iodine supplementation in preterm infants with follow-up at 2 years.

Trial started: 2010  Trial ended: 2015

Show Publications Published Protocol
  • Williams F, Hume R, Ogston S, Brocklehurst P, Morgan K, Juszczak E. A Summary of the Iodine Supplementation Study Protocol (I2S2): A UK Multicentre Randomised Controlled Trial in Preterm Infants. Neonatology. 2014;105(4):282-9
    http://www.ncbi.nlm.nih.gov/pubmed/24576827

INFANT

(Supported trial)

STATUS: Archive

A multicentre randomised controlled trial of an intelligent system to support decision making in the management of labour using the cardiotocogram.

Trial started: 2010  Trial ended: 2015

NPEU role: Randomisation service, statistical analysis and economic evaluation. Trial website: https://www.ucl.ac.uk/comprehensive-clinical-trials-unit/intelligent-fetal-monitoring-study

Show Publications
  • Brocklehurst P, Field D, Greene K, Juszczak E, Kenyon S, Linsell L, et al. Computerised interpretation of the fetal heart rate during labour: a randomised controlled trial (INFANT). Health Technol Assess. 2018;22(9):1-186.
    http://dx.doi.org/10.3310/hta22090
  • The INFANT Collaborative Group. Computerised interpretation of fetal heart rate during labour (INFANT): a randomised controlled trial. Lancet. 2017;389(10080):1719-29
    http://dx.doi.org/10.1016/ S0140-6736(17)30568-8
  • Barber VL, L. Locock, L. Powell, L. Shakeshaft, C. Lean, K. Colman, J. Juszczak, E. Brocklehurst, P. Electronic fetal monitoring during labour and anxiety levels in women taking part in a RCT. British Journal of Midwifery. 2013;21(6):394-403.
    https://doi.org/10.12968/bjom.2013.21.6.394
Published Protocol
  • Brocklehurst P, on behalf of the INFANT Collaborative Group. A study of an intelligent system to support decision making in the management of labour using the cardiotocograph - the INFANT study protocol. BMC Pregnancy Childbirth. 2016;16(1):10.
    https://doi.org/10.1186/s12884-015-0780-0

INIS

STATUS: Archive

International Neonatal Immunotherapy Study.

Trial started: 2001  Trial ended: 2007

Show Publications
  • The INIS Collaborative Group, Brocklehurst P, Farrell B, King A, Juszczak E, Darlow B, Haque K, Salt A, Stenson B, Tarnow-Mordi W. Treatment of neonatal sepsis with intravenous immune globulin. N Engl J Med. 2011;365(13):1201-11.
    http://www.ncbi.nlm.nih.gov/pubmed/21962214
Published Protocol
  • The INIS Study Collaborative Group. The INIS Study. International Neonatal Immunotherapy Study: non-specific intravenous immunoglobulin therapy for suspected or proven neonatal sepsis: an international, placebo controlled, multicentre randomised trial. BMC Pregnancy and Childbirth 2008, 8:52.
    http://www.ncbi.nlm.nih.gov/pubmed/19063731

INLET

STATUS: Archive

Cluster trial of newsletters and educational supplements to centres participating in INIS trial.

Trial started: 2006  Trial ended: 2009

Intra-umbilical vein injection

(Supported trial)

STATUS: Archive

Intra-umbilical vein injection in the management of retained placenta.

Trial started: 1991  Trial ended: 1995

NPEU role: Advisory.

Ipswich Perineal Suturing Trial

(Supported trial)

STATUS: Archive

The Ipswich Childbirth Study - a randomised trial to evaluate a policy of leaving the perineal skin unsutured when repairing trauma sustained during normal vaginal delivery.

Trial started: 1992  Trial ended: 1994

NPEU role: Data processing and analysis.

Show Publications
  • Grant A, Gordon B, Mackrodat C, Fern E, Truesdale A, Ayers S. The Ipswich childbirth study: one year follow up of alternative methods used in perineal repair. BJOG. 2001;108(1):34-40.
    http://www.ncbi.nlm.nih.gov/pubmed/11213002
  • Gordon B, Mackrodt C, Fern E, Truesdale A, Ayers S, Grant A. The Ipswich Childbirth Study: 1. A randomised evaluation of two stage postpartum perineal repair leaving the skin unsutured. Br J Obstet Gynaecol. 1998;105(4):435-40.
    http://www.ncbi.nlm.nih.gov/pubmed/9609272
  • Mackrodt C, Gordon B, Fern E, Ayers S, Truesdale A, Grant A. The Ipswich Childbirth Study: 2. A randomised comparison of polyglactin 910 with chromic catgut for postpartum perineal repair. Br J Obstet Gynaecol. 1998;105(4):441-5.
    http://www.ncbi.nlm.nih.gov/pubmed/9609273

MAIN Trial

STATUS: Archive

Multicentre randomised controlled trial of alternative treatments for inverted and non-protractile nipples in pregnancy.

Trial started: 1989  Trial ended: 1992

Show Publications
  • The MAIN Trial Collaborative Group. Preparing for breast feeding: treatment of inverted and non-protractile nipples in pregnancy. Midwifery. 1994;10(4):200-14.
    http://www.ncbi.nlm.nih.gov/pubmed/7837987
  • Alexander JM, Grant AM, Campbell MJ. Randomised controlled trial of breast shells and Hoffman's exercises for inverted and non-protractile nipples. BMJ. 1992;304(6833):1030-2.
    http://www.ncbi.nlm.nih.gov/pubmed/1586788

Minidex

STATUS: Archive

Minidex: The efficacy and safety of very low dose dexamethasone used to facilitate the extubation of ventilator dependent preterm babies who are at high risk of bronchopulmonary dysplasia.

Trial started: 2015  Trial ended: 2018

Show Publications
  • Yates H, Chiocchia V, Linsell L, Orsi N, Juszczak E, Johnson K, et al. Very low-dose dexamethasone to facilitate extubation of preterm babies at risk of bronchopulmonary dysplasia: the MINIDEX feasibility RCT. NIHR Journals Library. 2019;6:8. ps://doi.org/10.3310/eme06080

MIST

STATUS: Archive

Miscarriage treatment (MIST) trial.

Trial started: 1997  Trial ended: 2001

Show Publications
  • Trinder J, Brocklehurst P, Porter R, Read M, Vyas S, Smith L. Management of miscarriage: expectant, medical, or surgical? Results of randomised controlled trial (miscarriage treatment (MIST) trial). BMJ. 2006;332(7552):1235-40.
    http://www.ncbi.nlm.nih.gov/pubmed/16707509
  • Petrou S, Trinder J, Brocklehurst P, Smith L. Economic evaluation of alternative management methods of first-trimester miscarriage based on results from the MIST trial. BJOG. 2006;113(8):879-89.
    http://www.ncbi.nlm.nih.gov/pubmed/16827823

STATUS: Analysis-and-dissemination

NeoCLEAR: Neonatal Champagne Lumbar punctures Every time - An RCT. A multicentre, randomised controlled 2x2 factorial trial to investigate techniques to increase lumbar puncture success

Trial started: 2017  Trial ended: 2020

Show Publications
  • Marshall ASJ, Scrivens A, Bell JL, Linsell L, Hardy P, Yong J, et al. Assessment of infant position and timing of stylet removal to improve lumbar puncture success in neonates (NeoCLEAR): an open-label, 2?×?2 factorial, randomised, controlled trial. The Lancet Child & Adolescent Health. Published online November 29, 2022.
    http://doi.org/10.1016/s2352-4642(22)00343-1
  • Marshall A, Sadarangani M, Scrivens A, Williams R, Yong J, Bowler U, et al. Champagne and bloody taps: can we improve the success rate of neonatal lumbar punctures? Infant. 2018;14(6):224-26
    https://www.abacusdx.com/media/NeoCLEAR.PDF
Published Protocol
  • Marshall ASJ, Sadarangani M, Scrivens A, Williams R, Yong J, Bowler U, Linsell L, Chiocchia V, Bell JL, Stokes C, Santhanadass P, Adams E, Juszczak E, Roehr CC, on behalf of the The Neo Clear Collaborative Group. Study protocol: NeoCLEAR: Neonatal Champagne Lumbar punctures Every time – An RCT: a multicentre, randomised controlled 2?×?2 factorial trial to investigate techniques to increase lumbar puncture success. BMC Pediatrics. 2020;20(1):165.
    https://doi.org/10.1186/s12887-020-02050-8

STATUS: Set-up

Avoiding routine gastric residual volume measurement in neonatal critical care: a multi-centre randomised controlled superiority trial

Trial started: 2022  Trial ended: 2026

NEST

STATUS: Archive

Neonatal ECMO Study of Temperature.

Trial started: 2006  Trial ended: 2012

Show Publications
  • Field D, Juszczak E, Linsell L, Azzopardi D, Cowan F, Marlow N, Edwards D. Neonatal ECMO study of temperature (NEST): a randomized controlled trial. Pediatrics. 2013;132(5):e1247-56.
    http://www.ncbi.nlm.nih.gov/pubmed/24144703
Published Protocol
  • Field DJ, Firmin R, Azzopardi DV, Cowan F, Juszczak E, Brocklehurst P, et al. Neonatal ECMO study of temperature (NEST) - a randomised controlled trial. BMC Pediatr. [Protocol] 2010;10:24.
    http://www.biomedcentral.com/1471-2431/10/24/

Newbury Maternity Care Study

STATUS: Archive

Trial started: 1984  Trial ended: 1985

Show Publications
  • Elbourne D, Richardson M, Chalmers I, Waterhouse I, Holt E. The Newbury Maternity Care Study: a randomized controlled trial to assess a policy of women holding their own obstetric records. Br J Obstet Gynaecol. 1987;94(7):612-9.
    http://www.ncbi.nlm.nih.gov/pubmed/3304403

OCTAVE

(Supported trial)

STATUS: Archive

Oxford Region Controlled Trial of Artificial Ventilation.

Trial started: 1983  Trial ended: 1986

NPEU role: Consultative.

Show Publications
  • OCTAVE Study Group. Multicentre randomised controlled trial of high against low frequency positive pressure ventilation. Oxford Region Controlled Trial of Artificial Ventilation OCTAVE Study Group. Arch Dis Child. 1991;66(7 Spec No):770-5.
    http://www.ncbi.nlm.nih.gov/pubmed/1863121

Oral Salbutamol in Twin Pregnancy

(Supported trial)

STATUS: Archive

Prevention of premature labour in twin pregnancy using prophylactic oral salbutamol.

Trial started: 1986  Trial ended: 1987

NPEU role: Computing support.

Show Publications
  • Ashworth MF, Spooner SF, Verkuyl DA, Waterman R, Ashurst HM. Failure to prevent preterm labour and delivery in twin pregnancy using prophylactic oral salbutamol. Br J Obstet Gynaecol. 1990;97(10):878-82.
    http://www.ncbi.nlm.nih.gov/pubmed/2223677

Oral Salbutamol Trial

STATUS: Archive

Randomised controlled trial of oral salbutamol in the prevention of low birthweight.

Trial started: 1984  Trial ended: 1985

Show Publications
  • Unpublished. However, study referred to in Keirse MJNC, Grant A, King JF. Preterm labour. In: Chalmers I, Enkin M, Keirse MJNC, eds. Effective care in pregnancy and childbirth. Oxford: Oxford University Press, 1989:633-46.

OSIRIS Surfactant Trial

STATUS: Archive

Open Study of Infants at high risk of or with Respiratory Insufficiency – the role of Surfactant.

Trial started: 1990  Trial ended: 1991

Show Publications
  • The OSIRIS Collaborative Group. Early versus delayed neonatal administration of a synthetic surfactant--the judgment of OSIRIS.The OSIRIS Collaborative Group (open study of infants at high risk of or with respiratory insufficiency-the role of surfactant). Lancet. 1992;340(8832):1363-9.
    http://www.ncbi.nlm.nih.gov/pubmed/1360087
  • Elbourne D.R. Early versus delayed administration of a synthetic surfactant: update on mortality for UK babies in the OSIRIS trial. Neonatal Monitor. 1995;11(June):5-8.

Oxford Midwives Cord Clamping Study

(Supported trial)

STATUS: Archive

Trial started: 1985  Trial ended: 1986

NPEU role: Advisory and computer analysis.

Show Publications
  • Oxford Midwives Research Group. A study of the relationship between the delivery to cord clamping interval and the time of cord separation. Midwifery. 1991;7(4):167-76.
    http://www.ncbi.nlm.nih.gov/pubmed/1779870

PEACH

STATUS: Archive

PEACH (Pilot study) Prevention of Pulmonary Emboli and Deep Venous Thromboses After Caesarean Section with Low Molecular Weight Heparin.

Trial started: 1998  Trial ended: 2001

Show Publications
  • Gates S, Brocklehurst P, Ayers S, Bowler U. Thromboprophylaxis and pregnancy: two randomized controlled pilot trials that used low-molecular-weight heparin. Am J Obstet Gynecol. 2004;191(4):1296-303.
    http://www.ncbi.nlm.nih.gov/pubmed/15507957

Peterborough Study

STATUS: Archive

The evaluation of ultrasonographic placental grading as a test of fetal well-being.

Trial started: 1983  Trial ended: 1987

Show Publications

STATUS: Analysis-and-dissemination

Pre-eclampsia in HOspital: Early iNductIon or eXpectant management

Trial started: 2014  Trial ended: 2020

Show Publications
  • Beardmore-Gray A, Seed PT, Fleminger J, Zwertbroek E, Bernardes T, Mol BW, Battersby C, Koopmans C, Broekhuijsen K, Boers K, Owens MY, Thornton J, Green M, Shennan AH, Groen H, Chappell LC. Planned delivery or expectant management in preeclampsia: an individual participant data meta-analysis. Am J Obstet Gynecol. 2022;227(2):218-30 e8.
    https://doi.org/10.1016/j.ajog.2022.04.034
  • Hunter R, Beardmore-Gray A, Greenland M, Linsell L, Juszczak E, Hardy P, et al. Cost-Utility Analysis of Planned Early Delivery or Expectant Management for Late Preterm Pre-eclampsia (PHOENIX). Pharmacoecon Open. 2022;6(5):723-33.
    https://doi.org/10.1007/s41669-022-00355-1
  • Beardmore-Gray A, Greenland M, Linsell L, Juszczak E, Hardy P, Placzek A, Hunter R, Sparkes J, Green M, Shennan A, Marlow N, Chappell LC. Two-year follow-up of infant and maternal outcomes after planned early delivery or expectant management for late preterm pre-eclampsia (PHOENIX): A randomised controlled trial. BJOG. 2022;129(10):1654-63.
    https://doi.org/10.1111/1471-0528.17167
  • Fleminger J, Duhig K, Seed PT, Brocklehurst P, Green M, Juszczak E, Marlow N, Shennan A, Chappell L. Factors influencing perinatal outcomes in women with preterm preeclampsia: A secondary analysis of the PHOENIX trial. Pregnancy Hypertens. 2021;26:91-3.
    https://doi.org/10.1016/j.preghy.2021.10.002
  • Duhig KE, Seed PT, Placzek A, Sparkes J, Hendy E, Gill C, et al. Prognostic indicators of severe disease in late preterm pre-eclampsia to guide decision making on timing of delivery: The PEACOCK study. Pregnancy Hypertens. 2021;24:90-5.
    https://doi.org/10.1016/j.preghy.2021.02.012
  • Duhig K, Seed PT, Placzek A, Sparkes J, Gill C, Brockbank A, et al. A prognostic model to guide decision-making on timing of delivery in late preterm pre-eclampsia: the PEACOCK prospective cohort study. Health Technol Assess. 2021;25:30.
    https://doi.org/10.3310/hta25300
  • McCarthy FP, O'Driscoll JM, Seed PT, Placzek A, Gill C, Sparkes J, et al. Multicenter Cohort Study, With a Nested Randomized Comparison, to Examine the Cardiovascular Impact of Preterm Preeclampsia. Hypertension. 2021;78(5):1382-94.
    https://doi.org/10.1161/HYPERTENSIONAHA.121.17171
  • McCarthy F, O'Driscoll J, Seed P, Brockbank A, Cox A, Gill C, et al. Planned delivery to improve postpartum cardiac function in women with preterm pre-eclampsia: the PHOEBE mechanisms of action study within the PHOENIX RCT. Efficacy and Mechanism Evaluation. 2021;8:1-28.
    https://doi.org/10.3310/eme08120
  • Chappell LC, Brocklehurst P, Green ME, Hunter R, Hardy P, Juszczak E, et al. Planned early delivery or expectant management for late preterm pre-eclampsia (PHOENIX): a randomised controlled trial. The Lancet. 2019;394(10204):1181-90.
    https://doi.org/10.1016/S0140-6736(19)31963-4
  • Chappell LC, Milne F, Shennan A. Is early induction or expectant management more beneficial in women with late preterm pre-eclampsia? BMJ. 2015;350:h191.
    https://doi.org/10.1136/bmj.h191
Published Protocol
  • Chappell LC, Green M, Marlow N, Sandall J, Hunter R, Robson S, et al. Planned delivery or expectant management for late preterm pre-eclampsia: study protocol for a randomised controlled trial (PHOENIX trial). Trials. 2019;20(1):85.
    https://doi.org/10.1186/s13063-018-3150-1

PHVD Trial

(Supported trial)

STATUS: Archive

Randomised controlled trial of drug therapy in neonatal post-haemorrhagic ventricular dilatation.

Trial started: 1992  Trial ended: 1995

NPEU role: Trial management advice as well as additional data management and analysis undertaken at the NPEU.

Show Publications
  • The International PHVD Drug Trial Group. International randomised controlled trial of acetazolamide and furosemide in posthaemorrhagic ventricular dilatation in infancy. Lancet. 1998;352(9126):433-40.
    http://www.ncbi.nlm.nih.gov/pubmed/9708751

PiPS

STATUS: Archive

Early administration to preterm infants of the probiotic bifidobacterium breve strain BBG to prevent infection and necrotising enterocolitis.

Trial started: 2010  Trial ended: 2014

Show Publications
  • Fleming P, Wilks M, Eaton S, Panton N, Hutchinson R, Akyempon A, Hardy P, Millar MR, Costeloe K. Bifidobacterium breve BBG-001 and intestinal barrier function in preterm babies: Exploratory Studies from the PiPS Trial. Pediatr Res. 2021;89(7):1818-24.
    http://dx.doi.org/10.1038/s41390-020-01135-5
  • Millar M, Seale J, Greenland M, Hardy P, Juszczak E, Wilks M, Panton N, Costeloe K, Wade WG. The Microbiome of Infants Recruited to a Randomised Placebo-controlled Probiotic Trial (PiPS Trial). EBioMedicine. 2017;20:255-62.
    http://dx.doi.org/10.1016/j.ebiom.2017.05.019
  • Costeloe K, Hardy P, Juszczak E, Wilks M, Millar MR. Bifidobacterium breve BBG-001 in very preterm infants: a randomised controlled phase 3 trial. Lancet. 2016;387(10019):649-60.
    http://dx.doi.org/10.1016/S0140-6736(15)01027-2

PITCHES

STATUS: Archive

Phase III trial in IntrahepaTic CHolestasis of pregnancy (ICP) to Evaluate urSodeoxycholic acid (UDCA) in improving perinatal outcomes

Trial started: 2015  Trial ended: 2019

Show Publications
  • Fleminger J SP, Smith A, Juszczak E, Dixon PH, Chambers J, Dorling J, Williamson C, Thornton JG, Chappell LC. Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a secondary analysis of the PITCHES trial. BJOG. 2021;128(6):1066-75.
    http://dx.doi.org/10.1111/1471-0528.16567
  • Chappell LC, Bell JL, Smith A, Linsell L, Juszczak E, Dixon PH, et al. Ursodeoxycholic acid versus placebo in women with intrahepatic cholestasis of pregnancy (PITCHES): a randomised controlled trial. The Lancet. 2019;394(10201):849-60.
    http://dx.doi.org/10.1016/ S0140-6736(19)31270-X
  • Chappell LC, Bell JL, Smith A, Rounding C, Bowler U, Linsell L, et al. Ursodeoxycholic acid to reduce adverse perinatal outcomes for intrahepatic cholestasis of pregnancy: the PITCHES RCT. NIHR Journals Library. 2020;7:9.
    http://dx.doi.org/10.3310/eme07090
  • Chappell LC, Gurung V, Seed PT, Chambers J, Williamson C, Thornton JG, et al. Ursodeoxycholic acid versus placebo, and early term delivery versus expectant management, in women with intrahepatic cholestasis of pregnancy: semifactorial randomised clinical trial. BMJ. 2012;344:e3799.
    https://doi.org/10.1136/bmj.e3799
Published Protocol
  • Chappell LC, Chambers J, Dixon PH, Dorling J, Hunter R, Bell JL, et al. Ursodeoxycholic acid versus placebo in the treatment of women with intrahepatic cholestasis of pregnancy (ICP) to improve perinatal outcomes: protocol for a randomised controlled trial (PITCHES). Trials. 2018;19(1):657.
    https://doi.org/10.1186/s13063-018-3018-4

(Supported trial)

STATUS: Recruiting

Positive End-Expiratory Pressure (PEEP) Levels during Resuscitation of Preterm Infants at Birth (The POLAR Trial)

Trial started: 2021  Trial ended: 2028

Poppi

STATUS: Archive

SHORT TITLE: Poppi - Procedural pain in premature infants. FULL TITLE: A blinded randomised controlled trial investigating the efficacy of morphine analgesia for procedural pain in infants

Trial started: 2015  Trial ended: 2018

Show Publications
  • Monk V, Moultrie F, Hartley C, Hoskin A, Green G, Bell JL, et al. Oral morphine analgesia for preventing pain during invasive procedures in non-ventilated premature infants in hospital: the Poppi RCT NIHR Journals Library. 2019;6(9).
    https://doi.org/10.3310/eme06090
  • Hartley C, Moultrie F, Hoskin A, Green G, Monk V, Bell JL, et al. Analgesic efficacy and safety of morphine in the Procedural Pain in Premature Infants (Poppi) study: randomised placebo-controlled trial. The Lancet. 2018;392(10164):2595-605.
    http://dx.doi.org/10.1016/ S0140-6736(18)31813-0
Published Protocol
  • Slater R, Hartley C, Moultrie F, Adams E, Juszczak E, Rogers R, et al. A blinded randomised placebo-controlled trial investigating the efficacy of morphine analgesia for procedural pain in infants: Trial protocol [version 2; peer review: 3 approved]. Wellcome open research. 2017;1(7).
    https://doi.org/10.12688/wellcomeopenres.10005.2

Programme of Midwifery Research (i) Long-term follow-up of West Berkshire Perineal Management Trial

STATUS: Archive

Part of the Programme of Midwifery Research on Problems in the Postnatal Period (i) Long-term follow-up of women who participated in the West Berkshire Perineal Management Trial

Trial started: 1985  Trial ended:

Show Publications

Programme of Midwifery Research (ii) Long-term follow-up of a comparison of glycerol impregnated chromic catgut with untreated chromic catgut for the repair of perineal trauma

STATUS: Archive

Part of the Programme of Midwifery Research on Problems in the Postnatal Period (ii) Long-term follow-up of women who particpated in the randomised comparison of glycerol impregnated chromic catgut (softgut) with untreated chromic catgut for the repair of perineal trauma

Trial started: 1982  Trial ended: 1982

Show Publications
  • Spencer JA, Grant A, Elbourne D, Garcia J, Sleep J. A randomized comparison of glycerol-impregnated chromic catgut with untreated chromic catgut for the repair of perineal trauma. Br J Obstet Gynaecol. 1986;93(5):426-30.
    http://www.ncbi.nlm.nih.gov/pubmed/3518787

Programme of Midwifery Research (iii) Trial of intensive postnatal pelvic floor exercises

STATUS: Archive

Part of the Programme of Midwifery Research on Problems in the Postnatal Period (iii) Randomised controlled trial of intensive postnatal pelvic floor exercises

Trial started: 1987  Trial ended:

Show Publications

Programme of Midwifery Research (iv) Trial of bath additives in the relief of postpartum perineal pain

STATUS: Archive

Part of the Programme of Midwifery Research on Problems in the Postnatal Period (iv) A randomised controlled trial to compare the routine addition of salt or Savlon Bath concentrate during bathing in the immediate post-partum period

Trial started: 1996  Trial ended:

Show Publications
  • Sleep J, Grant AM. Salt in bath water: A randomised controlled trial to compare the routine addition of salt or Savlon Bath concentrate during bathing in the immediate post-partum period. Research and the Midwife Conference Proceedings 1987 London: King's College; 1988. p. 65-75.

Programme of Midwifery Research (v) Trial of alternative treatments for 'late' dyspareunia following vaginal delivery

(Supported trial)

STATUS: Archive

Part of the Programme of Midwifery Research on Problems in the Postnatal Period (v) Randomised controlled trial of alternative treatments for 'late' dyspareunia following vaginal delivery (Milton Keynes Dyspareunia Study)

Trial started: 1985  Trial ended:

NPEU role: Advice given on trial design, conduct, analysis and reporting.

Show Publications

Programme of Midwifery Research (vi) Trial of ultrasound, pulsed electromagnetic energy treatment of the severely traumatised perineum

STATUS: Archive

Part of the Programme of Midwifery Research on Problems in the Postnatal Period (vi) Randomised controlled trial to compare ultrasound, pulsed electromagnetic energy and 'placebo' therapy for the treatment of the severely traumatised perineum (Reading ultrasound and pulsed electromagnetic energy therapy)

Trial started: 1986  Trial ended:

Show Publications
  • Grant A, Sleep J, McIntosh J, Ashurst H. Ultrasound and pulsed electromagnetic energy treatment for perineal trauma. A randomized placebo-controlled trial. Br J Obstet Gynaecol. 1989;96(4):434-9.
    http://www.ncbi.nlm.nih.gov/pubmed/2665802

PROGRAMS

STATUS: Archive

A multicentre, randomised controlled trial of Prophylactic Granulocyte-Macrophage colony-stimulating factor (GM-CSF) to reduce Sepsis in preterm neonates

Trial started: 2000  Trial ended: 2012

Show Publications
  • Marlow N, Morris T, Brocklehurst P, Carr R, Cowan FM, Patel N, Petrou S, Redshaw ME, Modi N, Dore C. A randomised trial of granulocyte-macrophage colony-stimulating factor for neonatal sepsis: outcomes at 2 years. Arch Dis Child Fetal Neonatal Ed. 2013;98(1):F46-53.
    http://www.ncbi.nlm.nih.gov/pubmed/22542709
  • Carr R, Brocklehurst P, Dore CJ, Modi N. Granulocyte-macrophage colony stimulating factor administered as prophylaxis for reduction of sepsis in extremely preterm, small for gestational age neonates (the PROGRAMS trial): a single-blind, multicentre, randomised controlled trial. Lancet. 2009;373(9659):226-33.
    http://www.ncbi.nlm.nih.gov/pubmed/19150703
  • Marlow N, Morris T, Brocklehurst P, Carr R, Cowan F, Patel N, et al. A randomised trial of granulocyte-macrophage colony-stimulating factor for neonatal sepsis: childhood outcomes at 5 years. Arch Dis Child Fetal Neonatal Ed. 2015.
    http://www.ncbi.nlm.nih.gov/pubmed/25922190

PROMMIS

(Supported trial)

STATUS: Archive

Prelabour Rupture Of the Membranes and MISoprostol. A multicentre randomised trial to evaluate oral misoprostol for inductin of labour following prelabour repture of the membranes.

Trial started: 2002  Trial ended: 2004

NPEU role: Randomisation service, design and management of database, interim analyses and final analysis.

Show Publications
  • Bricker L, Peden H, Tomlinson AJ, Al-Hussaini TK, Idama T, Candelier C, Luckas M, Furniss H, Davies A, Kumar B, Roberts J, Alfirevic Z. Titrated low-dose vaginal and/or oral misoprostol to induce labour for prelabour membrane rupture: a randomised trial. BJOG. 2008;115(12):1503-11.
    http://www.ncbi.nlm.nih.gov/pubmed/18752586

Randomised controlled trial to compare three types of fetal scalp electrode

(Supported trial)

STATUS: Archive

Fetal Scalp Electrode Trial.

Trial started: 1988  Trial ended: 1988

NPEU role: Advice given on protocol devleopment. NPEU conducted the analysis.

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SIFT

STATUS: Archive

A multi-centre randomised controlled trial of two speeds of daily increment of milk feeding in very preterm or very low birth weight infants.

Trial started: 2013  Trial ended: 2019

Show Publications
  • Juszczak E, Hewer O, Partlett C, Hurd M, Bari V, Bowler U, et al. Evaluation of the effectiveness of an incentive strategy on the questionnaire response rate in parents of premature babies: a randomised controlled Study Within A Trial (SWAT) nested within SIFT. Trials. 2021;22(1):554.
    https://doi.org/10.1186/s13063-021-05515-y
  • Dorling J, Hewer O, Hurd M, Bari V, Bosiak B, Bowler U,et al. Two speeds of increasing milk feeds for very preterm or very low-birthweight infants: the SIFT RCT. Health Technol Assess. 2020;24(18):1-94.
    https://doi.org/10.3310/hta24180
  • Dorling J, Abbott J, Berrington J, Bosiak B, Bowler U, Boyle E, et al. Controlled Trial of Two Incremental Milk-Feeding Rates in Preterm Infants. N Engl J Med. 2019;381(15):1434-43.
    https://doi.org/10.1056/NEJMoa1816654
  • The SIFT Investigators Group. Early enteral feeding strategies for very preterm infants: current evidence from Cochrane reviews. Arch Dis Child Fetal Neonatal Ed. 2013;98(6):F470-2.
    http://www.ncbi.nlm.nih.gov/pubmed/23766343
Published Protocol
  • Abbott J, Berrington J, Bowler U, Boyle E, Dorling J, Embleton N, et al. The Speed of Increasing milk Feeds: a randomised controlled trial. BMC Pediatr. 2017;17(1):39.
    https://doi.org/10.1186/s12887-017-0794-z

Social support and pregnancy outcome

(Supported trial)

STATUS: Archive

Trial started: 1985  Trial ended: 1988

NPEU role: Consultative.

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Southmead Suturing Trial

(Supported trial)

STATUS: Archive

The Southmead perineal suture study. A randomised controlled trial of suture materials and suturing techniques for repair of perineal trauma.

Trial started: 1985  Trial ended:

NPEU role: Design, data processing and analysis.

Show Publications
  • Mahomed K, Grant A, Ashurst H, James D. The Southmead perineal suture study. A randomized comparison of suture materials and suturing techniques for repair of perineal trauma. Br J Obstet Gynaecol. 1989;96(11):1272-80.
    http://www.ncbi.nlm.nih.gov/pubmed/2558705

STATUS: Recruiting

SURFactant Or Not: Multicentre open label, pragmatic randomised controlled trial of early surfactant therapy versus expectant management in late preterm and early term infants with respiratory distress.

Trial started: 2019  Trial ended: 2022

TEAMS

STATUS: Archive

Randomised controlled trial to evaluate the effect of repeated courses of antenatal corticosteroids versus a single course on short term neonatal morbidity and long term neurodeveloment.

Trial started: 1999  Trial ended: 2003

The TOBY Children Study (Follow up at school age)

STATUS: Archive

Outcome at School Age Following Treatment With Whole Body Hypothermia After Perinatal Asphyxial Encephalopathy.

Trial started: 2009  Trial ended: 2013

Show Publications
  • Rivero-Arias O, Eddama O, Azzopardi D, Edwards AD, Strohm B, Campbell H. Hypothermia for perinatal asphyxia: trial-based resource use and costs at 6-7 years. Arch Dis Child Fetal Neonatal Ed. 2019 May;104(3):F285-F292. doi: 10.1136/archdischild-2017-314685
  • Campbell H, Eddama O, Azzopardi D, Edwards AD, Strohm B, Rivero-Arias O. Hypothermia for perinatal asphyxia: trial-based quality of life at 6-7 years. Arch Dis Child. 2018;103(7):654-9. doi:10.1136/archdischild-2017-313733
  • Azzopardi D, Strohm B, Marlow N, Brocklehurst P, Deierl A, Eddama O, Goodwin J, Halliday HL, Juszczak E, Kapellou O, Levene M, Linsell L, Omar O, Thoresen M, Tusor N, Whitelaw A, Edwards AD. Effects of Hypothermia for Perinatal Asphyxia on Childhood Outcomes. N Engl J Med. 2014;371(2):140-9.
    http://www.ncbi.nlm.nih.gov/pubmed/25006720

STATUS: Set-up

Treating Oesophageal Atresia to prevent Stricture: A multicentre, randomised trial of gastric acid suppression medication for treating oesophageal atresia to prevent stricture

Trial started: 2021  Trial ended: 2028

TOBY

STATUS: Archive

Whole body hypothermia for the treatment of perinatal asphyxial encephalopathy.

Trial started: 2002  Trial ended: 2008

Show Publications
  • Azzopardi D, Strohm B, Linsell L, Hobson A, Juszczak E, Kurinczuk JJ, et al. Implementation and conduct of therapeutic hypothermia for perinatal asphyxial encephalopathy in the UK-analysis of national data. PLoS One. 2012;7(6):e38504.
    https://doi.org/10.1371/journal.pone.0038504
  • Strohm B, Hobson A, Brocklehurst P, Edwards AD, Azzopardi D. Subcutaneous fat necrosis after moderate therapeutic hypothermia in neonates. Pediatrics. 2011;128(2):e450-2.
    https://doi.org/10.1542/peds.2010-3508
  • Strohm B, Azzopardi D. Temperature control during therapeutic moderate whole-body hypothermia for neonatal encephalopathy. Arch Dis Child Fetal Neonatal Ed. 2010;95(5):F373-5.
    https://doi.org/10.1136/adc.2009.163816
  • Rutherford M, Ramenghi LA, Edwards AD, Brocklehurst P, Halliday H, Levene M, et al. Assessment of brain tissue injury after moderate hypothermia in neonates with hypoxic-ischaemic encephalopathy: a nested substudy of a randomised controlled trial. Lancet Neurol. 2010;9(1):39-45.
    https://doi.org/10.1016/S1474-4422(09)70295-9
  • Regier DA, Petrou S, Henderson J, Eddama O, Patel N, Strohm B, et al. Cost-effectiveness of therapeutic hypothermia to treat neonatal encephalopathy. Value Health. 2010;13(6):695-702.
    https://doi.org/10.1111/j.1524-4733.2010.00731.x
  • Edwards AD, Brocklehurst P, Gunn AJ, Halliday H, Juszczak E, Levene M, et al. Neurological outcomes at 18 months of age after moderate hypothermia for perinatal hypoxic ischaemic encephalopathy: synthesis and meta-analysis of trial data. BMJ. 2010;340:c363.
    https://doi.org/10.1136/bmj.c363
  • Azzopardi DV, Strohm B, Edwards AD, Dyet L, Halliday HL, Juszczak E, Kapellou O, Levene M, Marlow N, Porter E, Thoresen M, Whitelaw A, Brocklehurst P. Moderate hypothermia to treat perinatal asphyxial encephalopathy. N Engl J Med. 2009;361(14):1349-58.
    http://www.ncbi.nlm.nih.gov/pubmed/19797281
  • Azzopardi D, Strohm B, Edwards AD, Halliday H, Juszczak E, Levene M, Thoresen M, Whitelaw A, Brocklehurst P. Treatment of asphyxiated newborns with moderate hypothermia in routine clinical practice: how cooling is managed in the UK outside a clinical trial. Arch Dis Child Fetal Neonatal Ed. 2009;94(4):F260-4.
    http://www.ncbi.nlm.nih.gov/pubmed/19060009
Published Protocol
  • Azzopardi D, Brocklehurst P, Edwards D, Halliday H, Levene M, Thoresen M, et al. The TOBY Study (Protocol). Whole body hypothermia for the treatment of perinatal asphyxial encephalopathy: A randomised controlled trial. BMC Pediatrics. [Protocol]. 2008;8(17):12 pages.
    http://www.biomedcentral.com/1471-2431/8/17

TOBY Xe

STATUS: Archive

Neuroprotective effects of hypothermia combined with inhaled xenon following perinatal asphyxia.

Trial started: 2012  Trial ended: 2014

Show Publications

STATUS: Analysis-and-dissemination

Timing of Stoma Closure in Neonates

Trial started: 2020  Trial ended: 2022

Show Publications
  • Ducey J, Kennedy AM, Linsell L, Woolfall K, Hall NJ, Gale C, et al. Timing of neonatal stoma closure: a survey of health professional perspectives and current practice. Archives of Disease in Childhood - Fetal and Neonatal Edition. 2021:fetalneonatal-2021-322040.
    http:// dx. doi. org/ 10. 1136/ archdischild2021- 322040

Treatment of umbilical cords

STATUS: Archive

Trial started: 1984  Trial ended: 1986

Show Publications
  • Mugford M, Somchiwong M, Waterhouse IL. Treatment of umbilical cords: a randomised trial to assess the effect of treatment methods on the work of midwives. Midwifery. 1986;2(4):177-86.
    http://www.ncbi.nlm.nih.gov/pubmed/3643399

TRH

STATUS: Archive

Antenatal TRH Trial: Randomised controlled trial of antenatal administration of thyrotropin releasing hormone (TRH) in women at risk of premature delivery.

Trial started: 1996  Trial ended: 1997

Show Publications
  • Alfirevic Z, Boer K, Borcklehurst P, Buimer M, Elbourne D, Kok J, Tansey S. Two trials of antenatal thyrotrophin-releasing hormone for fetal maturation: stopping before the due date. Antenatal TRH Trial and the Thyroneth Trial Groups. Br J Obstet Gynaecol. 1999;106(9):898-906.
    http://www.ncbi.nlm.nih.gov/pubmed/10492099

Ventriculomegaly Trial

STATUS: Archive

Randomised controlled trial to compare early versus conservative management of post-haemorrhagic ventricular dilatation in neonates. (Trial of early tapping in neonatal posthaemorrhagic ventricular dilatation).

Trial started: 1984  Trial ended: 1989

Show Publications
  • Ventriculomegaly Trial Group. Randomised trial of early tapping in neonatal posthaemorrhagic ventricular dilatation: results at 30 months. Arch Dis Child Fetal Neonatal Ed. 1994;70(2):F129-36.
    http://www.ncbi.nlm.nih.gov/pubmed/7512322
  • Ventriculomegaly Trial Group. Randomised trial of early tapping in neonatal posthaemorrhagic ventricular dilatation. Arch Dis Child. 1990;65(1 Spec No):3-10.
    http://www.ncbi.nlm.nih.gov/pubmed/2407200

West Berkshire perineal management trial / Reading Episiotomy Study

STATUS: Archive

West Berkshire perineal management trial.

Trial started: 1984  Trial ended:

Show Publications

STATUS: Analysis-and-dissemination

WithHolding Enteral feeds Around packed red cell Transfusion to prevent necrotising enterocolitis in preterm neonates: a multi-centre, electronic patient record (EPR), randomised controlled point-of-care pilot trial

Trial started: 2018  Trial ended: 2019

Show Publications
  • WHEAT Pilot Trial Qualitative Study (Study Within A Trial) McLeish J, Alderdice F, Robberts H, Cole C, Dorling J, Gale C. Challenges of a simplified opt-out consent process in a neonatal randomised controlled trial: qualitative study of parents’ and health professionals’ views and experiences. Arch Dis Child Fetal Neonatal Ed. 2020:fetalneonatal-2020-319545.
    http://dx.doi.org/10.1136/archdischild-2020-319545
Published Protocol
  • Gale C, Modi N, Jawad S, Culshaw L, Dorling J, Bowler U, et al. The WHEAT pilot trial-WithHolding Enteral feeds Around packed red cell Transfusion to prevent necrotising enterocolitis in preterm neonates: a multicentre, electronic patient record (EPR), randomised controlled point-of-care pilot trial. BMJ open. 2019;9(9):e033543.
    http:// dx. doi. org/ 10. 1136/ bmjopen- 2019033543

Zimbabwe Trials

(Supported trial)

STATUS: Archive

Randomised controlled trial to test whether a policy of bed rest, from 28-30 weeks gestation until delivery, lengthens the duration of gestation, improves fetal growth and decreases neonatal morbidity in twin pregnancy.

Trial started: 1985  Trial ended: 1986

NPEU role: Computing support.

Show Publications
  • Crowther CA, Verkuyl DA, Neilson JP, Bannerman C, Ashurst HM. The effects of hospitalization for rest on fetal growth, neonatal morbidity and length of gestation in twin pregnancy. Br J Obstet Gynaecol. 1990;97(10):872-7.
    http://www.ncbi.nlm.nih.gov/pubmed/2223676

Zimbabwe Trials

(Supported trial)

STATUS: Archive

Randomised controlled trial to test whether a policy of admission to hospital for rest is of value in the management of women with non-proteinuric hypertension during pregnancy.

Trial started: 1984  Trial ended: 1986

NPEU role: Computing support.

Show Publications
  • Crowther CA, Bouwmeester AM, Ashurst HM. Does admission to hospital for bed rest prevent disease progression or improve fetal outcome in pregnancy complicated by non-proteinuric hypertension? Br J Obstet Gynaecol. 1992;99(1):13-7.
    http://www.ncbi.nlm.nih.gov/pubmed/1547164