Phase 2
N=220
Trial II of Lung Protection With Azithromycin in the Preterm Infant
Bronchopulmonary Dysplasia
Bottom Line
View on ClinicalTrials.gov: NCT00319956 ↗Enrolled (actual)
220
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Incidence of Bronchopulmonary Dysplasia (BPD) — 76; 84 percentage w/ BPD — p=0.20
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Azithromycin (Drug); Placebo (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Hubert Ballard
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Bronchopulmonary Dysplasia (BPD) |
76; 84 | 0.20 |
Summary
The hypothesis of this study is that administration of azithromycin to ventilated premature infants will decrease the incidence and severity of BPD.
The purpose of this study is to determine if Azithromycin treatment is beneficial for prevention of bronchopulmonary dysplasia in preterm infants.
Eligibility Criteria
Inclusion Criteria
- birthweight less than 1250 grams admitted to UK NICU
- mechanical ventilation within the first 72 hours of life
Exclusion Criteria
- confirmed sepsis by blood culture
- multiple congenital anomalies or known syndromes
- intrauterine growth retardation with birthweight less than 10%ile for gestational age
- ROM for >7 days
Data sourced from ClinicalTrials.gov (NCT00319956). 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.