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

Active, not recruiting
Conditions
Growth Failure
Prematurity
Growth Disorders
Interventions
Other: Caloric Requirement
Registration Number
NCT03761498
Lead Sponsor
University of Texas Southwestern Medical Center
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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
118
Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Slow GrowthCaloric RequirementRequire more than 110 kcal/kg/day to maintain growth curve
Primary Outcome Measures
NameTimeMethod
quantitative rT-PCR of stool microbiome8-10 weeks depending on length of stay in NICU

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Parkland Hopsital and Health System

🇺🇸

Dallas, Texas, United States

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