The Impact of Human Milk Oligosaccharide 2'-Fucosyllactose

Premature Birth Clinical Trial

— 2'FL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04718662
• Other study ID #: IRB17-00035
• Status: Recruiting
• Phase: N/A
• Start date: July 4, 2018
• Est. completion date: January 12, 2023

Study information

• Verified date: January 2021
• Source: Nationwide Children's Hospital
• Contact: Kristi Small, BS
• Phone: 6143556649
• Email: kristi.small[@]nationwidechildrens.org
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 12, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Days

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth

Intervention

Dietary Supplement:
• 2'-fucosyllactose
Oligosaccharide added to infant's breast milk diet (or placebo)
• Placebo
Oral dextrose

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight in kilograms	Infant weight in kilograms (kg) will be measured weekly from week 1 of postnatal life to 36 weeks corrected GA or hospital discharge (whichever comes sooner).	NICU course (or from birth thru 36 weeks PMA)
Primary	Height in centimeters	Infant height in centimeters (cm) will be measured weekly from week 1 of postnatal life to 36 weeks corrected GA or hospital discharge (whichever comes sooner).	NICU course (or from birth thru 36 weeks PMA)
Primary	Head circumference in centimeters	Infant head circumference in centimeters (cm) will be measured weekly from week 1 of postnatal life to 36 weeks corrected GA or hospital discharge (whichever comes sooner).	NICU course (or from birth thru 36 weeks PMA)
Secondary	Time to full enteral feedings	Time to full enteral feeding will be measured in days from the time of starting feedings in the trial to the time of achieving 135 mL/kg/day.	NICU course (or from birth thru 36 weeks PMA)