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NCT03229967 · ClinicalTrials.gov registry record
Gastrointestinal Microbiome Influence on the Development of Bronchopulmonary Dysplasia
A clinical trial, sponsored by University of Tennessee.
- Completed
- Registry status
- 197
- Enrollment target
NCT03229967: Completed study, sponsored by University of Tennessee.
NCT03229967 is a clinical trial that has completed, run by University of Tennessee. The registered enrollment target is 197 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03229967 has completed, sponsored by University of Tennessee.
- COMPLETED
- Registry status
- 197 participants
- Enrollment target
Study Summary
The purpose of this study is to advance our knowledge of the factors that contribute to the development of bronchopulmonary dysplasia (BPD), a chronic lung affecting premature infants. Specifically, the investigators will determine the complexity of the gut microbiota, the genera of the bacteria that naturally live in the gut, and determine if the relative diversity of the gut bacteria is a prognostic indicator of BPD. To accomplish this, the investigators propose to characterize the microbiota of human premature newborns with BPD, then validate this potential mechanism in mice. The investigators will enroll very low birthweight premature infants admitted to the neonatal intensive care units (NICU) at Le Bonheur Children's Hospital and Regional One Health that are at high risk to develop BPD. A cohort of well full term newborns will also be enrolled. Non-invasive stool samples will be obtained weekly over the first month of life. Infants that eventually develop BPD will be paired with infants that did not develop BPD. Stool samples from these infants will be sent for analysis. The investigators expect that reduced complexity of the gut microbiome is associated with BPD. The investigators will model the contribution of reduced microbiome complexity to the risk to develop BPD or death, as well as the association with disease severity. The project investigates important factors leading to the development of BPD, and has the potential to directly translate to therapy for the most significant pulmonary complication of prematurity.
Primary Outcome
National Institute of Child Health and Disease (NICHD) consensus definition
Interventions
- DIAGNOSTIC_TEST 16S rRNA stool microbiome sequencing.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2017-07-05 |
| Est. Completion | 2020-12-30 |
What the finished NCT03229967 record still lists
NCT03229967 is an observational study that tracks outcomes without assigning an intervention. The registered 197 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which 16S rRNA stool microbiome sequencing. is the first listed.
NCT03229967 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03229967 about?
NCT03229967 is a clinical study titled "Gastrointestinal Microbiome Influence on the Development of Bronchopulmonary Dysplasia". The purpose of this study is to advance our knowledge of the factors that contribute to the development of bronchopulmonary dysplasia (BPD), a chronic lung affecting premature infants. Specifically, the investigators will determine the complexity of the gut microbiota, the genera of the bacteria tha...
What is the current status of trial NCT03229967?
This trial is currently completed. The enrollment target is 197 participants. The study started on 2017-07-05. Estimated completion is 2020-12-30.
What interventions are being tested in trial NCT03229967?
The interventions under investigation include: 16S rRNA stool microbiome sequencing. (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03229967?
This trial is sponsored by University of Tennessee, which has 96 total clinical trials registered on ClinicalTrials.gov.
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