- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03761498
Is There a Microbiome Associated With Poor Growth in Preterm Infants?
April 12, 2024 updated by: Katherine Anne Stumpf, University of Texas Southwestern Medical Center
This study evaluates the relationship between growth and stool microbiota in premature infants.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
118
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Katherinw Stumpf, MD
- Phone Number: 314-401-8456
- Email: katherine.stumpf@utsouthwestern.edu
Study Contact Backup
- Name: Julie Mirpuri, MD
- Phone Number: 214-648-3903
- Email: julie.mirpuri@utsouthwestern.edu
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75235
- Parkland Hopsital and Health System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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
|
Infants will be provided standard of care and given calories required to maintain appropriate growth per unit policies already in place.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
8-10 weeks depending on length of stay in NICU
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2019
Primary Completion (Estimated)
December 30, 2024
Study Completion (Estimated)
December 30, 2025
Study Registration Dates
First Submitted
November 29, 2018
First Submitted That Met QC Criteria
November 29, 2018
First Posted (Actual)
December 3, 2018
Study Record Updates
Last Update Posted (Estimated)
April 15, 2024
Last Update Submitted That Met QC Criteria
April 12, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU 042018-061
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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