Prebiotic in Preterm Infants

Not Applicable

Completed

• Conditions: Nutrition; Preterm Infant; Development, Infant
• Interventions: Dietary Supplement: Dextrose Control; Dietary Supplement: Prebiotic

• Registration Number: NCT03306316
• Lead Sponsor: Nationwide Children's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-28
• Study First Submitted QC: 2017-10-04
• Study First Posted: 2017-10-11
• Study Start: 2018-07-04
• Primary Completion: 2023-07-01
• Study Completion: 2023-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Dextrose Control	Placebo Control Arm
Experimental	Prebiotic	Experimental Arm

Primary Outcome Measures

Name	Time	Method
Weight	Enrollment through study day 45	Compare weight
Head Circumference	Enrollment through study day 45	Compare head circumference
Length	Enrollment through study day 45	Compare length

Secondary Outcome Measures

Name	Time	Method
Adaptation	Enrollment through study day 45	Compare time to enteral autonomy

Trial Locations

Locations (1)

Nationwide Children's Hospital and affiliated NICUs; 🇺🇸 Columbus, Ohio, United States