For another project, which I will explain later, I have been trying to find recent large multicentre trials in very preterm babies. I searched PubMed for “Randomized Controlled Trial’, and “Multicentre study”, then filtered by Human and Newborn and Preterm and just looked at the last 10 years. So far here is the impressive list of Acronyms for the trials in approximately reverse chronological order: See how many you can recognize! There will be a prize for anyone who gets them all!
SAIL, ETTNEO, MOBYDICK, LIFT, PENUT, SIFT, PREMOD2, RAINBOW, CORD PILOT, STOP-BPD, PLANET-2, PROPREMS, Reduce-ROP, CPAP-wean, NEUROSIS, HUMID, NEWNO, APTS, N3RO, PHELBI, PIPS, rhEPO, NEON, PREMILOC, BOOST2 UK, BOOST2 Aus, COT, SafeBoosc2, TENS, COIN, SUPPORT, TIPP, CAP, PINT, ELFIN, ADEPT, STOP-ROP, ETROP, BEAT-ROP, CRYO-ROP, VON-DR, INIS
The prize I have in my mind is my admiration! There were one or two that I had to search hard to find the acronym, and there are a couple of trials which aren’t in the list because I could not find one at all (such as the budesonide/surfactant trial).
The reason I have been trying to list all the recent large trials is to see if I can develop a database of evidence-based treatments for the most immature babies that we treat, of 22, 23 and 24 weeks gestation. The physiological immaturity of these babies is so extreme that for some interventions it is likely that their response may be different. I am searching to see which trials included such immature babies, and whether there are any data presented for infants under 25 weeks. So far… not much, but when I complete the search I will write it up as a publication, and let you all know on this blog.
If any readers know of a large RCT which included extremely immature babies and which is not on the list, please let me know, especially if data are presented for the gestational age stratum <25 weeks.
Neonatal Research 
Heart Rate Characteristics (HeRO) trial. The data were reported separately for ELBW infants showing a 26% reduction in all-cause mortality in that group. Also, Schelonka et al recently reported on the neurodevelopmental follow up on these patients with no change to the primary outcome (death-or-NDI) but statistically significant improvements in some secondary outcomes (eg. death, death-or-severe-CP).
Thanks! That didn’t come up in my search, shows that just using the Pubmed filters can miss important data. I will add that to my list
Hi keith, one trial that comes to mind is the NINSAP trial, for babies born before 26 weeks by Kribs et al. LISA vs intubation at birth. This is a very interesting project, if ever you are looking for co-authors/investigators, I would be very interested.
Thanks, they just published their long term follow-up data, will add that to the list also.
Hi Keith, One thing I have been thinking about a lot in similar lines: 22-24 weeks infants are definitely different than infants >24 weeks GA. A lot of the older trials did not include them, were pre antenatal steroids and multiple practices are also different now. So how do we put the results of these RCTs (a lot of which are easily >10-12 years old now) into current practice? I also question meta analysis data which include all the RCTs, some of which may be 20+ year old! What do you think?
When it comes to the relevance for infants less than 24 weeks, studies more than 20 years old will have included vanishingly small numbers of those babies, I think we are better off when it comes to data for the 24 weeks babies. But even among more recent studies which didn’t exclude the most immature, there are likely to be very few babies of 22 and 23 weeks gestation, as they are actually quite rare! They take up a lot of our time, as they often have complicated neonatal courses, but even a large trial which only looks at babies under 28 weeks, for example, will have a small subgroup under 24 weeks.
The budesonide/surfactant trial led by A/Prof Brett Manley and Dr Omar Kamlin is the PLUSS trial. Inclusion criteria: infants 22-27+6 weeks gestation.