Follow up of the PREMILOC post

Further to my post about the PREMILOC trial of routine hydrocortisone supplementation in extremely preterm infants, I received an email response from Olivier Baud, who was generally in agreement with my comments, but doubts the validity of adding the data of Biswas to the off-the-cuff meta-analysis that I presented.

First of all, I appreciate the real rigor required to perform a systematic review/meta-analysis correctly. I put the data together quickly to give me (and my readers) a quick view of where the data place us currently; an appropriately performed SR may well give a somewhat different interpretation, but what we can say is that, at present, the data are not at all overwhelming, and it is appropriate to wait until someone does the synthesis properly.

Secondly, I appreciate that the inclusion of Biswas is questionable, it was an RCT of both tri-iodothyronine and hydrocortisone. Infants under 30 weeks gestation were eligible if they were ventilated and less than 5 hours of age. Given that the only effect of the T3 appears to be a suppression of endogenous thryoid function with no beneficial pulmonary effects, I think a case can be made for including it, but I am certainly open to the idea that removing it from the analysis should be considered, at least as a sensitivity analysis. So I have done that, and it makes little difference to the results, neither death nor BPD are “statistically significant” when Biswas is removed, but the combined outcome death or BPD has an upper confidence limit which is slightly further away from 1.0. Relative risk without Biswas 0.86, 95% CI 0.76, 0.96.

Dr Baud also noted that the follow up of the babies in the PREMILOC trial is near to complete. Hopefully we will have some more answers soon.

About keithbarrington

I am a neonatologist and clinical researcher at Sainte Justine University Health Center in Montréal
This entry was posted in Neonatal Research and tagged , , . Bookmark the permalink.

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