The role of randomised trials

Radomised trials are evidently useful for developing treatment methods and procedures and often have a direct impact on the practices that take place in our health care systems on a daily basis. The blog post below highlights another important role of randomised trials, namely in deciding whether subsequent trials are necessary. Click on the link for further information:

A warm welcome to...

Baby-OSCAR is getting ready to launch the Main Trial; we extend a warm welcome to: Bradford Royal Infirmary, and Luton & Dunstable Hospital, who will be joining the five sites from the Pilot Study, namely: Birmingham Women's Hospital, Liverpool Women's Hospital, Norfolk & Norwich University Hospital, James Cook University Hospital and the University Hospital of North Tees.

Hospital Volume and Mortality due to preterm PDA

Download: Hospital Volume and Mortality due to preterm PDA

Nobuaki Michihata,1 Hiroki Matsui,1 Kiyohide Fushimi2 and Hideo Yasunaga1
1Department of Clinical Epidemiology and Health Economics, School of Public Health, University of Tokyo, and 2Department of Health Policy and Informatics, Tokyo Medical and Dental University Graduate School of Medicine, Tokyo, Japan

Abstract Background: Preterm patent ductus arteriosus (PDA) requires neonatal intensive care. The relationship between hospital volume and mortality of PDA remains poorly understood.

Methods: This was a retrospective observational study, using a national inpatient database in Japan. We identified patients who were diagnosed with PDA; exclusion criteria were as follows: (i) other cardiac complications; (ii) mild PDA treated without oral/i.v. indomethacin, surgery, or catheter intervention; (iii) age >1 year at admission; (iv) gestational age ?32 weeks; (v) death within 3 days of admission; and (vi) transferal to other hospitals. Information was collected using the Japanese Diagnosis Procedure Combination database from July 2010 to March 2013. Hospital volume was defined as the average annual number of neonates with gestational age <32 weeks at each hospital. The outcome measure was in-hospital mortality.

Results: A total of 2437 eligible patients treated at 199 hospitals were included. Low, medium, and high volume were defined as average annual number of preterm infants <34, 34–65, and >65, respectively. There were no significant differences in in-hospital mortality according to hospital volume. In-hospital mortality was identical in patients who received indomethacin alone, surgical or catheter intervention, or both after adjustment for patient background.

Conclusions: There was no significant relationship between hospital volume and in-hospital mortality due to preterm PDA. Centralization of patients with this condition may not be necessary

Click on the image above for the full article.

Comparison of two dose regimens of ibuprofen for the closure of patent ductus arteriosus in preterm newborns

The below abstract is from an article that compares a high dose regime (20-10-10) of ibuprofen to the low-dose (10-5-5) regime that we are using in the Baby-OSCAR Trial to treal PDA in preterm infants.


Objective: To compare the efficacy of intravenous ibuprofen at high (20-10-10 mg/kg/dose) and low doses (10-5-5 mg/kg/dose) the closure of patent ductus arteriosus in preterm newborns.

Methods: A cohort study with historical control of newborns that received high- and low-dose intravenous ibuprofen, from 2010 to 2013 in a neonatal intensive care unit, for closure of the patent ductus arteriosus, documented by echocardiography. Secondary outcomes included the number of ibuprofen cycles, incidence of bronchopulmonary dysplasia, necrotizing enterocolitis, changes in renal function, and death.

Results: Seventy-seven patients received three doses of ibuprofen for the treatment of patent ductus arteriosus, with 33 receiving high-dose and 44 low-dose therapy. The ductus closed after the first cycle in 25 (56.8%) low-dose patients and in 17 (51.5%) high-dose patients (p > 0.99). Sixteen patients received a second cycle of ibuprofen, and the ductus closed in 50% after low-dose and in 60% after high-dose therapy (p > 0.99). Seven patients required surgery for ductus closure, 13.6% in the low-dose group and 3% in the high-dose group (p = 0.22). Thirtynine patients developed bronchopulmonary dysplasia, 50% in the low-dose group and 51.5% in the high-dose group (p > 0.99). Twenty-two (50%) low-dose patients died vs. 15 (45.5%) high-dose patients (p = 0.86).

Conclusions: There was no difference in closure of the ductus arteriosus or occurrence of adverse effects between the two dose regimens.

© 2016 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. This is an open access article under the CC BY-NC-ND license (

Ref: Dornelles LV, Corso AL, Silveira RC, Procianoy RS. Comparison of two dose regimens of ibuprofen for the closureof patent ductus arteriosus in preterm newborns. J Pediatr (Rio J). 2016;92:314---8.

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This study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme (Reference Number 11/92/15). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.