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NCT03761498 Clinical Trial

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

Prematurity Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03761498
Other study ID # STU 042018-061
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 15, 2019
Est. completion date December 30, 2025

Study information
Verified date April 2024
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 118
Est. completion date December 30, 2025
Est. primary completion date December 30, 2024
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Parkland Hopsital and Health System Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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