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Clinical Trials/NCT03761498
NCT03761498
Active, not recruiting
Not Applicable

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

University of Texas Southwestern Medical Center1 site in 1 country118 target enrollmentJuly 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Growth Disorders
Sponsor
University of Texas Southwestern Medical Center
Enrollment
118
Locations
1
Primary Endpoint
quantitative rT-PCR of stool microbiome
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
July 15, 2019
End Date
December 30, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Katherine Anne Stumpf

Assistant Professor of Pediatrics

University of Texas Southwestern Medical Center

Eligibility Criteria

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.

Outcomes

Primary Outcomes

quantitative rT-PCR of stool microbiome

Time Frame: 8-10 weeks depending on length of stay in NICU

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

Study Sites (1)

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