The Impact of Human Milk Oligosaccharide 2'-Fucosyllactose
The Impact of Human Milk Oligosaccharide 2'-Fucosyllactose
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.
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.
Inclusion Criteria:

 -  1. Subjects will be preterm infants born 26 0/7 week to 31 6/7 weeks.

 -  2. Subjects will have a birthweight of greater than or equal to 700 grams to less than
 or equal to 1800 grams, appropriate for gestational age (AGA; defined as birth weight
 between 10th and 90th percentile on Fenton growth curve).

 -  3. Subject's parent(s) or legal guardian(s) have voluntarily signed and dated an
 informed consent form (ICF), approved by Nationwide Children's Hospital Institutional
 Review Board (IRB) which covers Nationwide Children's Hospital and The Ohio State
 University Wexner Medical Center, as well as the specific hospital providing care
 (i.e. Riverside Methodist Hospital). They have also provided Health Insurance
 Portability and Accountability Act (HIPAA) (or other applicable privacy regulation)
 authorization prior to any participation in the study.

 -  4. Signed consent is obtained by day 10 after birth.

 -  5. Mother plans to provide her own milk or consents to use of donor human milk in
 NICU.

 Exclusion Criteria:

 -  1. Subject has known congenital anomalies.

 -  2. Administration of enteral clinical product must be initiated by 9 ± 2 days of life
 (birth date is day of life 0).

 -  3. Confirmed necrotizing enterocolitis (Bell's Stage II or III, Appendix J) or
 confirmed sepsis (positive culture requiring antibiotic treatment).

 -  4. Steroid use at time of randomization

 -  5. Mechanical ventilator dependence.

 -  6. >2 days of systemic antimicrobial use prior to enrollment