Study of Feeding Tolerance and Growth in Preterm Infants Using a Liquid Supplement with Two Human Milk Oligosaccharides

What this Trial Is About

Researchers are studying the effects of a liquid supplement containing two specific human milk oligosaccharides 2-fucosyllactose and lacto-N-neotetraose on feeding tolerance, growth, and certain adverse events in preterm infants. This post-market study compares infants receiving the supplement with historical data from infants who followed the same nutrition protocols but did not receive the supplement. The aim is to understand how this supplement affects time to reach full enteral feeding, growth, and safety in a real-world setting. The study involves giving the HMO liquid supplement to preterm infants 3 to 4 times daily, separately from feedings. This supplement is designed to be administered without mixing into other feedings. The study compares these infants to a historical group from each site who were not exposed to the supplement but followed the same local feeding protocols. There are no placebo or masking procedures. Participants will be monitored from birth until they reach full enteral feeding, typically 1 to 3 weeks, with further assessments up to 13 weeks until discharge from the neonatal intensive care unit NICU. Researchers will evaluate feeding tolerance, gastrointestinal tolerance, weight gain, length growth, head circumference growth, as well as record any adverse or serious adverse events during this period. The study tracks growth and safety outcomes to better understand the supplements impact on preterm infant health.

Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs)