N/A
Completed N=27
A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome
Premature Birth of Newborn · Enterocolitis, Necrotizing
Source: ClinicalTrials.gov NCT02477423 ↗
Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Richness of the Preterm Infant Microbiome — 12.8; 11 16S rRNA gene amplicon sequence variants
Summary
The purpose of this study is to determine whether antibiotics given immediately after birth alter the development of the developing preterm infant's microbiome, which may further alter overall clinical outcomes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Richness of the Preterm Infant Microbiome |
12.8; 11 | — |
| PRIMARY Shannon Diversity of the Preterm Infant Microbiome |
5; 3.8 | — |
| SECONDARY Chronic Lung Disease of Infancy (CLD) |
0; 0 | — |
| SECONDARY Necrotizing Enterocolitis (NEC) |
0; 0 | — |
| SECONDARY Retinopathy of Prematurity (ROP) |
0; 0 | — |
| SECONDARY Intraventricular Hemorrhage (IVH) |
0; 0 | — |
| SECONDARY Death |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria for antibiotic randomization:
- Infant must be born between the gestational ages of 28 0/7 weeks and 34 6/7 weeks
-AND-
- Infant must be born at investigator's home institution.
-AND-
- Infant must be considered to have a low risk of infection by one of the following criteria:
- Delivered for maternal indications (Cesarean section or induction of labor for maternal health, including pre-eclampsia, placental abruption, history of intrauterine fetal demise (IUFD)/abruption, multiple gestation requiring preterm delivery, etc) -OR-
- Delivered due to preterm labor to a mother without the diagnosis of chorioamnionitis/maternal fever or prolonged rupture of membranes >18 hours
Exclusion Criteria for antibiotic randomization:
- Signs of clinical illness within the first 3 hours of life:
- 5-minute Apgar 40%
- Immature: Total (I:T) Ratio of >0.2 on initial complete blood count (CBC)
- Congenital anomalies, including renal anomalies requiring serum antibiotic level monitoring
ANY infant born between the gestational ages of 28 0/7 weeks and 34 6/7 weeks who do not meet inclusion criteria, with parental consent, can participate in the stool analysis only arm of the study.
Data sourced from ClinicalTrials.gov (NCT02477423). 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. Informational only — not medical advice.