Is There a Microbiome Associated With Poor Growth in Preterm Infants?

NCT03761498 | Active Not Recruiting

• 1 other identifier: STU 042018-061
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the relationship between growth and stool microbiota in premature infants.

Conditions

Growth Disorders; Growth Failure; Prematurity

Outcome Measures

Primary Outcomes (1)

• quantitative rT-PCR of stool microbiome

  alpha diversity of bacterial groups in normal growth vs. poor growth

  8-10 weeks depending on length of stay in NICU

Study Arms (2)

Normal Growth

Require less than or equal to 110 kcal/kg/day to maintain growth curve

Slow Growth

Require more than 110 kcal/kg/day to maintain growth curve

Other: Caloric Requirement

Interventions

Caloric Requirement OTHER

Infants will be provided standard of care and given calories required to maintain appropriate growth per unit policies already in place.

Slow Growth

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants born at less than 28 weeks gestation will be eligible from birth until discharge. Infants with major congenital anomalies which alter growth patterns will be excluded.

You may qualify if:

• All infants less than 28 weeks gestation who are admitted to the Parkland Hospital NICU.

You may not qualify if:

• Infants \>27 weeks gestation. Infants with major congenital anomalies which may alter growth patterns.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Hopsital and Health System

Dallas, Texas, 75235, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples

MeSH Terms

Conditions

Growth Disorders; Failure to Thrive; Premature Birth

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 3, 2018
• Study Start: July 15, 2019
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)