Prebiotic in Preterm Infants

NCT03306316 | Completed DMC

• 1 other identifier: ColumbusCRI
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Infant; Development, Infant; Nutrition

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Adaptation

  Enrollment through study day 45

Other Outcomes (3)

• Neurobehavior

  Enrollment through study day 45

• Gut inflammation

  Enrollment through study day 45

• Fecal microbiome

  Enrollment through study day 45

Study Arms (2)

Experimental

EXPERIMENTAL

Experimental Arm

Dietary Supplement: Prebiotic

Control

PLACEBO COMPARATOR

Placebo Control Arm

Dietary Supplement: Dextrose Control

Interventions

Prebiotic DIETARY_SUPPLEMENT

Prebiotic experimental group

Also known as: Study product

Experimental

Dextrose Control DIETARY_SUPPLEMENT

Dextrose Control

Control

Eligibility Criteria

• Age: 7 Days - 10 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects will be preterm infants born 700 and 1800 g birthweight (inclusive), and \>/=26 weeks to 31 6/7 weeks.
• 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.
• Signed consent is obtained by day 10 after birth.
• Mother plans to provide her own milk or consents to use of donor human milk in NICU.

You may not qualify if:

• Infants with the following conditions or situations at the time of randomization will be excluded from the study:
• Subject has known congenital anomalies.
• Administration of enteral clinical product must be initiated by 9 ± 2 days of life (birth date is day of life 0).
• Confirmed necrotizing enterocolitis (Bell's Stage II or III, Appendix J) or confirmed sepsis (positive culture requiring antibiotic treatment).
• Steroid use at time of randomization
• Mechanical ventilator dependence.
• \>2 days of antimicrobial use prior to enrollment
• Maternal incapacity: including maternal opioids, cocaine or alcohol abuse during pregnancy or current
• Mother or infant is currently receiving treatment consistent with HIV therapy.
• Mother plans to formula feed exclusively and has not consented to use of donor milk during NICU stay.
• Infant with intraventricular hemorrhage

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital and affiliated NICUs

Columbus, Ohio, 43206, United States

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Prebiotics

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Pediatrics

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 11, 2017
• Study Start: July 4, 2018
• Primary Completion: July 1, 2023
• Study Completion: December 31, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)