PAS 2018 No1: SAIL away (and another mention by a science journalist).

For some reason there is a small epidemic (n=2, that’s a pico-epidemic) of articles about probiotics and necrotising enterocolitis this year in the mainstream press. I was interviewed, and I am mentioned again, in this article on the NOVA “next” website, which is open access ww.pbs.org/wgbh/nova/next/body/probiotics-for-preemies 

I have just returned the PAS meeting, where I sometimes get invited to lunch to eat with groups of amazing neonatal fellows, such as the fellows from Columbia, who, with the leadership of Tina Leone, are doing great work. Thanks for lunch, and the stimulating interactions.

Also it is where this year there were several large important neonatal trials being presented, I usually only post about studies after peer review, but the large clinical trials don’t usually change much between PAS presentation and final publication. So I will post about SAIL, STOP-BPD, TOLERATE-PDA, SCAMP, and a randomized trial of propranolol for treating retinopathy, which sadly doesn’t seem to have an acronym.

I decided I would write a few posts and divide them up as the mood takes me…

Here is the first, the SAIL trial, a very high quality trial of a very important issue.

SAIL is a trial of sustained inflations in preterm infants during resuscitation. This was a multicenter trial (registration NCT02139800 ) of which theprotocol has been published (and is open access); extremely preterm babies 23 to 26 weeks were enrolled at birth if they needed respiratory assistance at birth.

In the control arm the babies were ventilated as usual, in the sustained inflation arm they had one or two prolonged sustained inflations, 20 cmH2O for the first, and 25 for the second (if needed) and then they continued NRP.

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The primary outcome was BPD or death. The study was stopped about 2/3 of the way through, with 425 babies analyzed. At that point there was no “statistically significant” difference in the primary outcome, but an excess of early deaths in the SI group, 7.5% compared to 1.4% of controls died within 48 hours of birth, which was considered to be highly unlikely to be due to chance (p<0.002).

Death before discharge was 33% higher in the SI group (relative risk 1.33 95% CI 0.9, 2.0), BPD was not reduced (it was actually 12% more frequent in the SI group), and the primary outcome was somewhat more frequent with SI overall, about a 10% increase in “death or BPD”; which was not “statistically significant” (as  is still often said) because the 95% confidence intervals include a relative risk of 1.0 (the relative risk of “death or BPD” was 1.10, 95% CI 0.9, 1.3).

Part 2 to follow 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.

2 Responses to PAS 2018 No1: SAIL away (and another mention by a science journalist).

  1. Re. SAIL, being a fellow at participating centre, I wondered, how we ensure uniformity in the technique of the intervention. I eagerly wait for the results. Also if the mask leak is taken into account to ensure the effectivity. The phase contrast imaging of the SI in the rabbits looks promising to establish FRC, bit surprised.

  2. drnosh says:

    Regarding SAIL, the phase contrast imaging on the rabbit lungs looks promising ( to establish FRC) while the rabbit is intubated. I wonder how consistent is the technique of the intervention with the face mask. Will be interesting to see if the mask leak is taken into account for the effectivity of the SI and also if HDS- PDA is related with the increased morbidity in the intervention arm.

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