PREMILOC Trial to Prevent Bronchopulmonary Dysplasia in Very Preterm Neonates

Phase 3 Completed 523 enrolled Assistance Publique - Hôpitaux de Paris

RandomizedParallel-groupTriple-blindTreatment

Summary

There is increasing evidence linking a fetal and early neonatal systemic inflammatory response syndrome to the subsequent development of bronchopulmonary dysplasia (BPD) and white matter injury (WMI) in very preterm infants. Babies with evidence of adrenal insufficiency early in life may not be able to control the inflammatory response and are thereby more likely to develop BPD than babies who do not show such evidence of inflammation. We designed a randomized controlled trial to test the hypothesis whether very preterm babies at high-risk of BPD, treated with low doses of HC during the first 10 days of life, are more likely to survive without BPD at 36 weeks of post-menstrual age (PMA), compared to babies treated with placebo.

Timeline

Start: 2008-04
Primary completion: 2016-01
Completion: 2016-01

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Hydrocortisone	Other / unclassified	0.5 mg/kg	Intravenous

PREMILOC Trial to Prevent Bronchopulmonary Dysplasia in Very Preterm Neonates

Summary

Timeline

Publications

Drugs

Indications