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PREMILOC Trial to Prevent Bronchopulmonary Dysplasia in Very Preterm Neonates (PREMILOC)

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ClinicalTrials.gov Identifier: NCT00623740
Recruitment Status : Completed
First Posted : February 26, 2008
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE February 7, 2008
First Posted Date  ICMJE February 26, 2008
Last Update Posted Date October 2, 2018
Study Start Date  ICMJE April 2008
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2008)
dichotomous variable: survival without BPD at 36 weeks PMA. [ Time Frame: add 8 to12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PREMILOC Trial to Prevent Bronchopulmonary Dysplasia in Very Preterm Neonates
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bronchopulmonary Dysplasia
Intervention  ICMJE
  • 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.
    Other Name: hydrocortisone upjohn 100mg
  • Drug: placebo
    intravenous slow of placebo 0.5mg/kg/12 hours during 7 days then 0.5 mg/kg/24 hours during 3 days
Study Arms  ICMJE
  • Experimental: 1: hydrocortisone
    1: active arm treated with low doses of HC during the first 10 days of life
    Intervention: Drug: hydrocortisone
  • Placebo Comparator: 2: Placebo
    2:placebo arm treated with placebo at the same conditions than active arm
    Intervention: Drug: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2014)
523
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2008)
786
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 24 Hours   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00623740
Other Study ID Numbers  ICMJE P 060250
2007-002041-20 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: olivier BAUD, Pr ASSISTANCE PULIQUE HOPITAUX DE PARIS
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP