The ProPrems trial: investigating the effects of probiotics on late onset sepsis in very preterm infants

Multicentre randomized placebo-controlled trial in very preterm infants from Australia and New Zealand. Infants were enrolled within 72 hours of birth if they were less than 32 weeks' gestation and weighed under 1500 g.

The active regimen was a daily oral probiotic powder containing Bifidobacterium infantis, Streptococcus thermophilus, and Bifidobacterium lactis, delivering 1.5 g and 1 x 10^9 total organisms per dose. It was started soon after the beginning of milk feeds and continued once daily until discharge home or term corrected age, given orally or via gastric tube.

This source packet provides the trial design and intended outcomes rather than completed efficacy results. The study was designed to test whether early daily probiotic supplementation reduces definite late-onset sepsis before 40 weeks' corrected age or discharge, with secondary outcomes including suspected sepsis, necrotizing enterocolitis, mortality, hospital stay, antibiotic use, and later allergic outcomes. The authors indicate that large, well-powered multicentre evidence is needed to establish safety and efficacy in this vulnerable population.

No completed outcome results or effect estimates are provided in this packet, so clinical efficacy cannot be determined from the available source. The intervention was tested in a very specific high-risk neonatal population, which limits generalizability, and the planned trial size and complex follow-up outcomes increase the risk of missing or incomplete endpoint data.