Trial medication is on its way to the next site due to open for recruitment, Jessop Wing, Sheffield.
These tiny ampoules contain either Ibuprofen 5mg/mL or Placebo Solution. As a masked, randomised placebo-controlled parallel group trial it is important that we do not know what is in the ampoules. This ensures that there is no bias when interpreting the study results, meaning that the trial is conducted and analysed with the highest integrity.
Since re-launching at the start of the month, our large team of researchers across the country have been busy, with 6 sites now open and another 10 to open in April. We are extremely grateful for the valuable work that these consultants and nurses do in looking after the babies in their care. We have had four new babies enrolled in the Baby-OSCAR Trial since re-launching, and our thanks also goes out to these families.
With four participants enrolled so far, Bradford has recruited ‘the first baby from a non-pilot site’. All the researchers are grateful to families, who help to improve knowledge and understanding by taking part in clinical trials and improve the care of babies in the future.
This retrospective cohort study compared two time periods of different approaches to PDA. In period I, all large PDA (more than 2 mm) were closed medically at a median age of 7 days and/or surgically at a median age of 12 days. In period II no treatment was offered.
The data suggests once PDA is symptomatic, it does not affect outcomes whether one closes a PDA or not. Investigators report higher incidence of BPD in period I when PDA was closed surgically (in ~80% babies). This could be the effect of surgery as this association has been reported earlier. It is surprising that, unlike previous reports, persistent PDA in this study was not associated with increased odds of death or NEC, but with significantly less BPD. The medication used in this study was indomethacin that is now known to have a poor side effect profile as compared to ibuprofen. The limitations of this study are that it is a single site, retrospective observational study in two time periods and uses indomethacin for medical treatment.
The results of this study, however, support the Baby-OSCAR protocol that a symptomatic PDA, if diagnosed after 7 days of age in ventilator dependent babies, does not necessarily benefit from medical and/or surgical treatment, and hence by limiting rescue or open-label treatment, we do not cause harm.
Mandatory Closure Versus Nonintervention for Patent Ductus Arteriosus in Very Preterm Infants
Se In Sung, MD*, Yun Sil Chang, MD*, Ji Young Chun, MD, Shin Ae Yoon, MD, Hye Soo Yoo, MD, So Yoon Ahn, MD, and Won Soon Park, MD
As part of the Baby-OSCAR Trial, parents will be contacted when their child(ren) reach(es) 2 years of age to complete a questionnaire about their child(ren)'s health and development. This will help us get a better picture of the study results.
Many trials will include an element of long-term follow-up; It is just as important to record the long-term effects as it is the immediate results following treatment.
By completing this long-term follow-up, the researchers can spot any long-term benefits to the treatments received, and also monitor any long-term negative outcomes. The conclusions of one such study demonstrate the importance of this follow-up stage in gaining the bigger picture for study results and how these follow-up developmental assessments can provide key information for future treatments and further trials. The results have been published in the following paper: Neurodevelopmental Outcome at 2 Years of Age according to Patent Ductus Arteriosus Management in Very Preterm Infants; Bourgoin, L. et al (Neonatology, 2016). You can read more about it by clicking on the link below.
After a year of manufacturing the new medication, the main trial has launched with Birmingham Women's Hospital kick starting the recruitment. Dr Rasiah and the team are part of a bigger pool of researchers, participating in Baby-OSCAR, helping to fill these knowledge gaps in the best care for babies who have been born early (prematurely) with a large PDA.
Photo courtesy of hospital website: http://www.bwnft.nhs.uk/
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.