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

NCT ID: NCT03761498

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-15

Study Completion Date

2025-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Growth Disorders Growth Failure Prematurity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal Growth

Require less than or equal to 110 kcal/kg/day to maintain growth curve

No interventions assigned to this group

Slow Growth

Require more than 110 kcal/kg/day to maintain growth curve

Caloric Requirement

Intervention Type OTHER

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

Interventions

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Caloric Requirement

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

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Katherine Anne Stumpf

Assistant Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Parkland Hopsital and Health System

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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STU 042018-061

Identifier Type: -

Identifier Source: org_study_id

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