Prebiotic in Preterm Infants

NCT ID: NCT03306316

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-04
• Study Completion Date: 2023-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental

Experimental Arm

Group Type: EXPERIMENTAL

Prebiotic

Intervention Type: DIETARY_SUPPLEMENT

Prebiotic experimental group

Control

Placebo Control Arm

Group Type: PLACEBO_COMPARATOR

Dextrose Control

Intervention Type: DIETARY_SUPPLEMENT

Dextrose Control

Interventions

Prebiotic

Prebiotic experimental group

Intervention Type: DIETARY_SUPPLEMENT

Dextrose Control

Dextrose Control

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Study product

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 7 Days
• Maximum Eligible Age: 10 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nationwide Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ethan Mezoff

Assistant Professor of Clinical Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nationwide Children's Hospital and affiliated NICUs

Columbus, Ohio, United States

Countries

United States

Other Identifiers

ColumbusCRI

Identifier Type: -

Identifier Source: org_study_id

NCT04718662

Identifier Type: -

Identifier Source: nct_alias