Status:
COMPLETED
PREMILOC Trial to Prevent Bronchopulmonary Dysplasia in Very Preterm Neonates
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Bronchopulmonary Dysplasia
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE3
Brief 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) ...
Detailed Description
Individual patients and study procedures. Entry criteria: gestational age between 24 weeks and 27 weeks + 6 days, babies born to mother with either clinical chorioamnionitis, preterm and prelabor rupt...
Eligibility Criteria
Inclusion
- Gestational age between 24 weeks and 27 weeks + 6 days
- Babies born to mother with either clinical chorioamnionitis, preterm and prelabor rupture of the membranes (PPROM), or preterm labor
- Written informed consent obtained before inclusion and randomization.
Exclusion
- Babies born to mothers with birth weight below the 3th percentile
- PPROM before 22 weeks
- Major fetal anomaly or congenital malformation
- Mother refusal or inability to provide consent.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
523 Patients enrolled
Trial Details
Trial ID
NCT00623740
Start Date
April 1 2008
End Date
January 1 2016
Last Update
October 2 2018
Active Locations (1)
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1
Hopital Robert Debre
Paris, France, 75019