PREMILOC Trial to Prevent Bronchopulmonary Dysplasia in Very Preterm Neonates

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Brief Title

PREMILOC Trial to Prevent Bronchopulmonary Dysplasia in Very Preterm Neonates

Official Title

Early Prevention of Broncho-pulmonary Dysplasia and Neonatal Mortality in Very Preterm Infants Using Low Dose of Hydrocortisone: a Randomized Controlled Trial

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) 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.
    

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 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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

dichotomous variable: survival without BPD at 36 weeks PMA.

Secondary Outcome

 features of WMI on MRI performed between 36-40 weeks PMA

Condition

Bronchopulmonary Dysplasia

Intervention

hydrocortisone

Study Arms / Comparison Groups

 1: hydrocortisone
Description:  1: active arm treated with low doses of HC during the first 10 days of life

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

523

Start Date

April 2008

Completion Date

January 2016

Primary Completion Date

January 2016

Eligibility Criteria

        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.
      

Gender

All

Ages

N/A - 24 Hours

Accepts Healthy Volunteers

No

Contacts

olivier BAUD, Pr, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT00623740

Organization ID

P 060250

Secondary IDs

2007-002041-20

Responsible Party

Sponsor

Study Sponsor

Assistance Publique - Hôpitaux de Paris


Study Sponsor

olivier BAUD, Pr, Principal Investigator, ASSISTANCE PULIQUE HOPITAUX DE PARIS


Verification Date

August 2016