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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03761498
Recruitment Status : Suspended (Covid-19)
First Posted : December 3, 2018
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

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

Condition or disease Intervention/treatment
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.

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Study Type : Observational
Estimated 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 : July 15, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2025

Group/Cohort 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.




Primary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Stool samples


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Preterm infants born at less than 28 weeks gestation will be eligible from birth until discharge. Infants with major congenital anomalies which alter growth patterns will be excluded.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03761498


Locations
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United States, Texas
Parkland Hopsital and Health System
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03761498    
Other Study ID Numbers: STU 042018-061
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Growth Disorders
Failure to Thrive
Pathologic Processes
Signs and Symptoms