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NCT02784821 · ClinicalTrials.gov registry record · Phase 2
Antibiotic "Dysbiosis" in Preterm Infants
A Phase 2 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 2
- Development phase
- 98
- Enrollment target
NCT02784821: Completed Phase 2 study, sponsored by University of Florida.
NCT02784821 is a Phase 2 study that has completed, run by University of Florida. The registered enrollment target is 98 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02784821, a Phase 2 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 98 participants
- Enrollment target
Study Summary
Prolonged antibiotic use in preterm neonates has significant consequences on the developing intestinal microbiome, metabolome and host response, predisposing the neonate to various major morbidities, including necrotizing enterocolitis (NEC), late-onset sepsis, bronchopulmonary dysplasia (BPD), and mortality. The hypothesis is that early and prolonged antibiotic use in preterm neonates has significant consequences on the developing intestinal microbiome, metabolome and host response, predisposing the neonate to various major morbidities. It is possible that the effect of this widespread antibiotic use outweighs the potential benefits. This study will randomize preterm infants born at less than 33 weeks gestation to either pre-emptive antibiotics or no-pre-emptive antibiotics. The purpose of this research is to evaluate the risks and benefits of current practice to determine optimal levels of antibiotic use that protects the babies from infection with minimal effect on the microbiome and subsequent adverse outcomes related to overuse of antibiotics.
Primary Outcome
Enrolled subjects' medical record will be reviewed to determine the number of patients with the composite outcome and the association between antibiotic administration and the components of the composite outcome
Interventions
- DRUG Antibiotic
- DRUG Antibiotics
- OTHER Gastric fluid
- OTHER Breast milk
- OTHER Stool samples
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2017-01-16 |
| Est. Completion | 2019-09-11 |
| Phase | Phase 2 |
What the finished NCT02784821 record still lists
NCT02784821 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 5 interventions - of which Antibiotic is the first listed.
NCT02784821 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02784821 about?
NCT02784821 is a clinical study titled "Antibiotic "Dysbiosis" in Preterm Infants". Prolonged antibiotic use in preterm neonates has significant consequences on the developing intestinal microbiome, metabolome and host response, predisposing the neonate to various major morbidities, including necrotizing enterocolitis (NEC), late-onset sepsis, bronchopulmonary dysplasia (BPD), and ...
What is the current status of trial NCT02784821?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2017-01-16. Estimated completion is 2019-09-11.
What interventions are being tested in trial NCT02784821?
The interventions under investigation include: Antibiotic (DRUG), Antibiotics (DRUG), Gastric fluid (OTHER), Breast milk (OTHER), Stool samples (OTHER).
Who is sponsoring clinical trial NCT02784821?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02784821's enrollment target sits among peer trials
98 743rd of 2000 higher than 1,255 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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