Phase 2
N=98
Antibiotic "Dysbiosis" in Preterm Infants
Enterocolitis, Necrotizing · Bacteremia · Bronchopulmonary Dysplasia · Intraventricular Hemorrhage · Periventricular Leukomalacia
Bottom Line
View on ClinicalTrials.gov: NCT02784821 ↗Enrolled (actual)
98
Serious AEs
1.0%
Results posted
Jun 2024
Primary outcome: Primary: Number of Events of Composite Morbidities and Mortality, Including Necrotizing Enterocolitis (NEC), Late Onset Sepsis (LOS), Bronchopulmonary Dysplasia (BPD) and Death — 19; 1; 9; 14 adverse events composite outcome
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Antibiotic (Drug); Gastric fluid (Other); Breast milk (Other); Stool samples (Other); Antibiotics (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Events of Composite Morbidities and Mortality, Including Necrotizing Enterocolitis (NEC), Late Onset Sepsis (LOS), Bronchopulmonary Dysplasia (BPD) and Death |
19; 1; 9; 14 | — |
| SECONDARY Number of Participants With Late Onset Sepsis |
6; 0; 5; 4 | — |
| SECONDARY Number of Participants With Bronchopulmonary Dysplasia (BPD) |
12; 1; 3; 8 | — |
| SECONDARY Number of Participants With Necrotizing Enterocolitis (NEC) |
1; 0; 2; 1 | — |
| SECONDARY Number of Deaths |
5; 0; 4; 5 | — |
| SECONDARY Length of Stay. |
26.5; 64.5; 53.9; 61.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- All infants less than 33 weeks gestation.
Exclusion Criteria
- Infants who are non-viable at birth.
Data sourced from ClinicalTrials.gov (NCT02784821). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.