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OpenTrials
Active, Not Recruiting

NCT Number: NCT03761498

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Growth Disorders Failure to Thrive Female Urogenital Diseases and Pregnancy Complications Growth Failure Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Prematurity Signs and Symptoms Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Parkland Hopsital and Health System

Dallas, Texas, 75235, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Caloric Requirement

Other

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2018
Registry last updated
Apr 1, 2025

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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