Prebiotic in Preterm Infants

The Impact of Prebiotic on Growth, Feeding Progression and Neurodevelopment in Preterm Infants

This is a double blinded, randomized, controlled trial of prebiotic in infants born between 26 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 prebiotic administration to human milk-fed infants who are 700 gram to 1800 gram birthweight. The goal of this study will be addressed through one primary aim, a secondary aim, and exploratory aims, indicated below:

Primary aim: Compare weight, length, and head circumference Z-score growth between the study and placebo groups.

Secondary aim: Compare the time taken to achieve full feedings (135 mL/kg/day or more) between the study and placebo groups.

Exploratory aim 1: Compare neurobehavior, as measured by the validated Neonatal intensive care unit Network Neurobehavioral Scale (NNNS), between the study and placebo groups.

Exploratory aim 2: Compare fecal calprotectin levels to determine the impact of supplementation on reducing intestinal inflammation between the study and placebo groups.

Exploratory aim 3: Compare fecal microbiome between the prebiotic and placebo groups, to determine whether there is a shift in microbial composition towards bifidobacteria and other microbes that are capable of metabolizing prebiotic.

Study Overview

• Status: Completed
• Conditions: Development, Infant; Nutrition; Preterm Infant
• Intervention / Treatment: Dietary supplement: Prebiotic; Dietary supplement: Dextrose Control

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43206
      • Nationwide Children's Hospital and affiliated NICUs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 1 week (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Preterm infants who meet the following inclusion criteria will be eligible for randomization:

  1. Subjects will be preterm infants born 700 and 1800 g birthweight (inclusive), and >/=26 weeks to 31 6/7 weeks.
  2. Subject's parent(s) or legal guardian(s) have voluntarily signed and dated an informed consent form (ICF). They have also provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.
  3. Signed consent is obtained by day 10 after birth.
  4. Mother plans to provide her own milk or consents to use of donor human milk in NICU.

Exclusion Criteria:

• Infants with the following conditions or situations at the time of randomization will be excluded from the study:

  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 antimicrobial use prior to enrollment
  7. Maternal incapacity: including maternal opioids, cocaine or alcohol abuse during pregnancy or current
  8. Mother or infant is currently receiving treatment consistent with HIV therapy.
  9. Mother plans to formula feed exclusively and has not consented to use of donor milk during NICU stay.
  10. Infant with intraventricular hemorrhage

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Experimental Arm	Dietary supplement: Prebiotic; Prebiotic experimental group; Other Names: Study product
Placebo Comparator: Control; Placebo Control Arm	Dietary supplement: Dextrose Control; Dextrose Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Compare weight	Enrollment through study day 45
Length	Compare length	Enrollment through study day 45
Head Circumference	Compare head circumference	Enrollment through study day 45

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adaptation	Compare time to enteral autonomy	Enrollment through study day 45

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurobehavior	Compare Neonatal intensive care unit Network Neurobehavioral Scale score	Enrollment through study day 45
Gut inflammation	Compare gut inflammation by measurement of fecal calprotectin	Enrollment through study day 45
Fecal microbiome	Compare fecal microbiome	Enrollment through study day 45

Collaborators and Investigators

• Sponsor: Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2018
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: September 28, 2017
• First Submitted That Met QC Criteria: October 4, 2017
• First Posted (Actual): October 11, 2017

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: ColumbusCRI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No