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The Impact of Human Milk Oligosaccharide 2'-Fucosyllactose — 2'FL  

Premature Birth Clinical Trial

Official title:
The Impact of Human Milk Oligosaccharide 2'-Fucosyllactose on Growth, Feeding Progression and Neurodevelopment in Preterm Infants

Clinical Trial Summary

This is a double blinded, randomized, controlled trial of 2'-Fucosyllactose in infants born between 29 and 32 weeks gestational age. The investigators anticipate enrollment of 90 subjects in total and for the study to be completed in 18 months. The investigators anticipate collecting clinical data, anthropometrics, stool samples (requiring appropriate storage through analysis), salivary samples from mother and infant, discarded blood samples from baby after the standard care lab tests are done, a single, optional blood draw at the conclusion of the study, and subjecting infants to a neurodevelopmental survey at study completion. The overall goal of this study is to test daily oral administration of 2'-FL 270 mg/day in the milk of human milk-fed infants who are >1000 gram to <1500 gram birthweight.

Clinical Trial Description

This will be a randomized, controlled trial, stratified on the mother's choice to feed her infant using primarily either her own milk or donor milk. Half of study infants will receive 2'-FL in their milk and half will receive the same quantity of placebo (dextrose) added to their milk. The first day the infant receives the test product (2'-FL or placebo) will be designated as study day 1 (SDAY1). Infants will be followed until study dat 66 (SDAY66) or hospital discharge, whichever comes first. The primary outcomes will be weight, length, and head circumference growth from the start of the trial to its completion. The secondary outcome will be time to achieving full enteral feeding (in days). Exploratory outcomes will be neurobehavioral test scores obtained from a standardized Newborn Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS) examination at 34 to 35 weeks corrected gestational age (GA); fecal calprotectin; and fecal microbiome. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04718662
Study type Interventional
Source Nationwide Children's Hospital
Contact Kristi Small, BS
Phone 6143556649
Email kristi.small@nationwidechildrens.org
Status Recruiting
Phase N/A
Start date July 4, 2018
Completion date January 12, 2023
View Details
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