Archived Trials

Acyclovir

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

Trial started
1990
Trial ended
1995

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

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Abnormal Doppler Enteral Prescription Trial.

Trial started
2006
Trial ended
2009

Publications

  • 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

ALPS

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Alternative Labour Pain management Study (pilot study).

Trial started
2004
Trial ended
2006

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

APPLE

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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

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

BLASP

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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

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

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

Trial started
2007
Trial ended
2014

Publications

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

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Bristol third stage management trial.

Trial started
1986
Trial ended
1987

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

CAESAR

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Trial of Caesarean Section Surgical Techniques.

Trial started
2000
Trial ended
2006

Publications

Cervical Cerclage Trial (CCT) main trial

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MRC/RCOG Cervical Cerclage Trial.

Trial started
1981
Trial ended
1988

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

Collaborative Eclampsia Trial

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

Trial started
1991
Trial ended
1994

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

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

Trial started
2007
Trial ended
2011

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

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

Trial started
2011
Trial ended
2015

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

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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

Publications

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

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

Trial started
1984
Trial ended
1992

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

Dublin Birthing Chair Trial

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The Coombe Lying-In Hospital Birthing Chair Trial.

Trial started
1984
Trial ended
1985

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

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

Trial started
1981
Trial ended
1985

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

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

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

Trial started
1990
Trial ended
1991

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

ECMO and follow up

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

Trial started
1993
Trial ended
1995

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

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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

Publications

Fetal Movements Trial

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Randomised trial of fetal movement counting.

Trial started
1985
Trial ended
1988

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

Hip Trial

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

Trial started
1994
Trial ended
1998

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

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The HOOP Study: Hands on or poised.

Trial started
1994
Trial ended
1996

Publications

I2S2

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

Trial started
2010
Trial ended
2015

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

INIS

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International Neonatal Immunotherapy Study.

Trial started
2001
Trial ended
2007

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

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

Trial started
2006
Trial ended
2009

MAIN Trial

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

Trial started
1989
Trial ended
1992

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

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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

MIST

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Miscarriage treatment (MIST) trial.

Trial started
1997
Trial ended
2001

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

NEST

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Neonatal ECMO Study of Temperature.

Trial started
2006
Trial ended
2012

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

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Trial started
1984
Trial ended
1985

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

Oral Salbutamol Trial

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

Trial started
1984
Trial ended
1985

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

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

Trial started
1990
Trial ended
1991

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.

PEACH

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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

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

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

Trial started
1983
Trial ended
1987

Publications

PiPS

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

Trial started
2010
Trial ended
2014

Publications

PITCHES

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

Trial started
2015
Trial ended
2019

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

Poppi

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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

Published Protocol

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

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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

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

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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

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

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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

Publications

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

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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

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

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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

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

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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

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

TEAMS

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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

Publications

  • [Pilot study. Not yet published]

The TOBY Children Study (Follow up at school age)

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

Trial started
2009
Trial ended
2013

Publications

  • 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

TOBY

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Whole body hypothermia for the treatment of perinatal asphyxial encephalopathy.

Trial started
2002
Trial ended
2008

Publications

  • 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

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

Trial started
2012
Trial ended
2014

Publications

Treatment of umbilical cords

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Trial started
1984
Trial ended
1986

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

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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

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

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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

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

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West Berkshire perineal management trial.

Trial started
1984
Trial ended

Publications