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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Growth Disorders; Growth Failure; Prematurity
• Intervention / Treatment: Other: Caloric Requirement

Detailed Description

Preterm infants often require increased caloric intake to maintain appropriate growth while in the neonatal intensive care unit (NICU). While some infants will have a clear source of need for greater calories, it is often not obvious why others require increased available calories to maintain appropriate growth. Emerging evidence suggests that patterns of gut microbiota may play a role in infant and childhood growth. We hypothesize that differences in the microbial pattern in preterm infants is related to poor growth and need for increased caloric intake. This may ultimately represent a therapeutic target to improve the growth of preterm infants in the NICU. This study aims to describe the differences in microbiome which may vary with growth pattern.

• Study Type: Observational
• Enrollment (Actual): 118

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Parkland Hopsital and Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Infants will be provided standard of care and given calories required to maintain appropriate growth per unit policies already in place.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: November 29, 2018
• First Submitted That Met QC Criteria: November 29, 2018
• First Posted (Actual): December 3, 2018

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Growth Disorders; Failure to Thrive
• Other Study ID Numbers: STU 042018-061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No