Overview

This trial is active, not recruiting.

Condition bronchopulmonary dysplasia
Treatments hydrocortisone, placebo
Phase phase 3
Sponsor Assistance Publique - Hôpitaux de Paris
Start date April 2008
End date January 2016
Trial size 523 participants
Trial identifier NCT00623740, 2007-002041-20, P 060250

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
1: active arm treated with low doses of HC during the first 10 days of life
hydrocortisone hydrocortisone upjohn 100mg
Intravenous slow of hemisuccinate hydrocortisone 0.5 mg/kg/12 hours during 7 days then 0.5mg/kg/24 hours during 3 days.
(Placebo Comparator)
2:placebo arm treated with placebo at the same conditions than active arm
placebo
intravenous slow of placebo 0.5mg/kg/12 hours during 7 days then 0.5 mg/kg/24 hours during 3 days

Primary Outcomes

Measure
dichotomous variable: survival without BPD at 36 weeks PMA.
time frame: add 8 to12

Secondary Outcomes

Measure
features of WMI on MRI performed between 36-40 weeks PMA
time frame: 8-12 weeks
neurodevelopmental outcome
time frame: 18 month-3 years
Death before discharge
time frame: discharge
BPD 28 days and 36 weeks
time frame: 28 days and 36 weeks
duration of mechanical ventilation and O2 supplementation
time frame: inclusion to discharge
need for vasopressors
time frame: inclusion to discharge

Eligibility Criteria

Male or female participants up to 24 hours old.

Inclusion Criteria: - 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 Criteria: - 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.

Additional Information

Official title Early Prevention of Broncho-pulmonary Dysplasia and Neonatal Mortality in Very Preterm Infants Using Low Dose of Hydrocortisone: a Randomized Controlled Trial
Principal investigator olivier BAUD, Pr
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 rupture of the membranes (PPROM), or preterm labor, written informed consent obtained before inclusion and randomization. Exclusion criteria: babies born with birth weight below the 3th percentile, PPROM before 22 weeks, major fetal anomaly or congenital malformation, mother refusal or inability to provide consent. Stratification: stratum A: 24-25 weeks and stratum B: 26-27 weeks. Centrally controlled randomization takes place between 12 and 48 hours of age and patients assigned to the HC group are treated with 0,5 mg/kg HC intravenously twice a day for seven days and once a day for the next three days. Ibuprofen is only given to babies with persistent ductus arteriosis (PDA) echocardiographically confirmed at 24 hours of age or older. Outcome variables. The primary outcome is a dichotomous variable: survival without BPD at 36 weeks PMA. A consistent physiologic definition of BPD will be used by all participating centres (Walsh MC, Pediatrics 2004;114:1305-11). Secondary outcome variables include features of WMI on MRI performed at 40 weeks PMA and neurodevelopmental outcome at 2-year of corrected age. Other outcome variables include death before discharge, BPD at 28 days and 36 weeks, duration of mechanical ventilation and O2 supplementation, need for vasopressors, use of open-labeled postnatal steroids (HC or dexamethasone), confirmed or suspected early and late onset sepsis, PDA, gastrointestinal perforation, NEC, ROP, IVH, biological markers of the neonatal inflammatory response syndrome.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.