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

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03761498

Collaborator

(none)

100

Enrollment

1

Location

77.5

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Growth Disorders Growth Failure Prematurity	Other: Caloric Requirement

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 15, 2019

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2025

Arms and Interventions

Arm

Intervention/Treatment

Normal Growth

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

Slow Growth

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

Other: Caloric Requirement

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

Outcome Measures

Primary Outcome Measures

quantitative rT-PCR of stool microbiome [8-10 weeks depending on length of stay in NICU]
alpha diversity of bacterial groups in normal growth vs. poor growth

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parkland Hopsital and Health System	Dallas	Texas	United States	75235

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Katherine Anne Stumpf, Assistant Professor of Pediatrics, University of Texas Southwestern Medical Center

ClinicalTrials.gov Identifier:

NCT03761498

Other Study ID Numbers:

STU 042018-061

First Posted:

Dec 3, 2018

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

No

Plan to Share IPD:

No

Studies a U.S. FDA-regulated Drug Product:

No

Studies a U.S. FDA-regulated Device Product:

No

Additional relevant MeSH terms:

Growth Disorders

Failure to Thrive

Study Results

No Results Posted as of Mar 31, 2022