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| Sponsor: | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Information provided by: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00623740 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bronchopulmonary Dysplasia |
Drug: hydrocortisone Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Early Prevention of Broncho-Pulmonary Dysplasia and Neonatal Mortality in Very Preterm Infants Using Low Dose of Hydrocortisone: a Randomized Controlled Trial |
| Estimated Enrollment: | 786 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
1: active arm treated with low doses of HC during the first 10 days of life
|
Drug: hydrocortisone
Intravenous slow of hemisuccinate hydrocortisone 0.5 mg/kg/12 hours during 7 days then 0.5mg/kg/24 hours during 3 days.
|
|
2: Placebo Comparator
2:placebo arm treated with placebo at the same conditions than active arm
|
Drug: placebo
intravenous slow of placebo 0.5mg/kg/12 hours during 7 days then 0.5 mg/kg/24 hours during 3 days
|
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 5th 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 arteriosus (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.
Eligibility| Ages Eligible for Study: | up to 24 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Olivier BAUD, Pr | 01 40 03 41 09 | olivier.baud@rdb.aphp.fr |
| France | |
| Hopital Robert Debre | Recruiting |
| PARIS, France, 75019 | |
| Contact: Olivier BAUD, Pr +33(0)1 40 03 41 09 olivier.baud@rdb.aphp.fr | |
| Principal Investigator: | olivier BAUD, Pr | ASSISTANCE PULIQUE HOPITAUX DE PARIS |
More Information
| Responsible Party: | Department Clinical Research of Developpement ( Amel OUSLIMANI ) |
| Study ID Numbers: | P 060250, N° EudraCT 2007-002041-20 |
| Study First Received: | February 7, 2008 |
| Last Updated: | April 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00623740 History of Changes |
| Health Authority: | France: Ministry of Health |
|
Hydrocortisone Very low birth weight Bronchopulmonary dysplasia Prevention Cerebral palsy |
|
Anti-Inflammatory Agents Bronchopulmonary Dysplasia Hydrocortisone Cortisol succinate Respiratory Tract Diseases Therapeutic Uses |
Lung Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Hydrocortisone acetate Pharmacologic Actions |
