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Prebiotic in Preterm Infants

Sponsor
Nationwide Children's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03306316
Collaborator
(none)
90
Enrollment
1
Location
2
Arms
53.9
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Prebiotic
  • Dietary Supplement: Dextrose Control
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
The Impact of Prebiotic on Growth, Feeding Progression and Neurodevelopment in Preterm Infants
Actual Study Start Date :
Jul 4, 2018
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Weight [Enrollment through study day 45]

      Compare weight

    2. Length [Enrollment through study day 45]

      Compare length

    3. Head Circumference [Enrollment through study day 45]

      Compare head circumference

    Secondary Outcome Measures

    1. Adaptation [Enrollment through study day 45]

      Compare time to enteral autonomy

    Other Outcome Measures

    1. Neurobehavior [Enrollment through study day 45]

      Compare Neonatal intensive care unit Network Neurobehavioral Scale score

    2. Gut inflammation [Enrollment through study day 45]

      Compare gut inflammation by measurement of fecal calprotectin

    3. Fecal microbiome [Enrollment through study day 45]

      Compare fecal microbiome

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Days to 10 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    1. 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.

    2. Signed consent is obtained by day 10 after birth.

    3. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nationwide Children's Hospital and affiliated NICUs Columbus Ohio United States 43206

    Sponsors and Collaborators

    • Nationwide Children's Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ethan Mezoff, Assistant Professor of Clinical Pediatrics, Nationwide Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT03306316
    Other Study ID Numbers:
    • ColumbusCRI
    • NCT04718662
    First Posted:
    Oct 11, 2017
    Last Update Posted:
    Jul 27, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Premature Birth

    Study Results

    No Results Posted as of Jul 27, 2021