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NCT05385939 · ClinicalTrials.gov registry record
Gastric Bacterial Colonization of Preterm Neonates
A clinical trial, sponsored by Christiana Care Health Services.
- Completed
- Registry status
- 122
- Enrollment target
NCT05385939: Completed study, sponsored by Christiana Care Health Services.
NCT05385939 is a clinical trial that has completed, run by Christiana Care Health Services. The registered enrollment target is 122 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05385939 has completed, sponsored by Christiana Care Health Services.
- COMPLETED
- Registry status
- 122 participants
- Enrollment target
Study Summary
This prospective cohort study was conducted in the Christiana Care Health System Neonatal Intensive Care Unit. It occurred at two time periods: Time period 1 included infants admitted to the traditional, open bay NICU. Time period 2 included infants admitted to the new private, single family room NICU. There was a 3 month period between Time period 1 and Time period 2 to ensure that there was no patient overlap. Stool samples and environmental samples were collected at 1 and 4 weeks after birth in both time periods. The objective of this study was to establish the gastrointestinal microbiome of infants born at less than 32 weeks gestation admitted to the exiting open bay NICU and compare it to the gastrointestinal microbiome of infants born at less than 32 weeks admitted to the new private, single family room NICU.
Primary Outcome
Microorganisms identified in stool samples obtained at weeks 1 and 4 of life using the 16s rRNA sequencing based technique.
Interventions
- OTHER Observational
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2022-05-01 |
What the finished NCT05385939 record still lists
NCT05385939 is an observational study that tracks outcomes without assigning an intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Observational is the first listed.
NCT05385939 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05385939 about?
NCT05385939 is a clinical study titled "Gastric Bacterial Colonization of Preterm Neonates". This prospective cohort study was conducted in the Christiana Care Health System Neonatal Intensive Care Unit. It occurred at two time periods: Time period 1 included infants admitted to the traditional, open bay NICU. Time period 2 included infants admitted to the new private, single family room NI...
What is the current status of trial NCT05385939?
This trial is currently completed. The enrollment target is 122 participants. The study started on 2019-04-01. Estimated completion is 2022-05-01.
What interventions are being tested in trial NCT05385939?
The interventions under investigation include: Observational (OTHER).
Who is sponsoring clinical trial NCT05385939?
This trial is sponsored by Christiana Care Health Services, which has 82 total clinical trials registered on ClinicalTrials.gov.
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