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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 is a Phase 2 study that has completed, run by University of Florida. The registered enrollment target is 98 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02784821
The ClinicalTrials.gov registry entry for NCT02784821 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Antibiotic is the first listed.
NCT02784821 reports 0 study locations.
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.
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