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Completed

NCT Number: NCT03306316

Prebiotic 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.

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Key information

Conditions

Preterm Infant Development, Infant Female Urogenital Diseases and Pregnancy Complications Nutrition Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

7 day–10 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital and affiliated NICUs

Columbus, Ohio, 43206, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Prebiotic

Dietary Supplement

Prebiotic experimental group

Other names: Study product

Dextrose Control

Dietary Supplement

Dextrose Control

Primary outcomes

  1. Weight

    Time frame: Enrollment through study day 45

    Compare weight

  2. Length

    Time frame: Enrollment through study day 45

    Compare length

  3. Head Circumference

    Time frame: Enrollment through study day 45

    Compare head circumference

Secondary outcomes

  1. Adaptation

    Time frame: Enrollment through study day 45

    Compare time to enteral autonomy

Other outcomes

  1. Neurobehavior

    Time frame: Enrollment through study day 45

    Compare Neonatal intensive care unit Network Neurobehavioral Scale score

  2. Gut inflammation

    Time frame: Enrollment through study day 45

    Compare gut inflammation by measurement of fecal calprotectin

  3. Fecal microbiome

    Time frame: Enrollment through study day 45

    Compare fecal microbiome

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Oct 11, 2017
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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