Clinical Trial: Betamethasone and Severity of Hyaline Membrane Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Betamethasone and Severity of Hyaline Membrane Disease in the Newborn Premature

Brief Summary: Primary purpose: to study the relationship between betamethasone placental transfer and the occurrence and severity of the Hyaline Membrane Disease.

Detailed Summary: β-Mhyalines is a prospective multicentric non interventional study. One hundred fifty pregnant women at risk of premature delivery, in the framework of Hyaline Membrane Disease of the neonate, will receive 2 intramuscular injections of Celesten (betamethasone) at 24 hours interval. Plasma samples will be collected: 2 in the mother before delivery, one maternal and one cord samples at delivery. Concentrations will be measured and analyzed using a population approach. A ratio between neonatal and maternal exposure will be calculated to represent placental transfer. The effect of covariates (genetic polymorphism for CYP3A4, CYP3A5, P-glycoprotein…, and others variables as gestational age, bodyweight at birth, apgar score, co-medication, maternal disease) will be tested to explain the variability of placental transfer. The relationship between placental transfer and the occurrence and severity of the Hyaline Membrane Disease will then be study, in order to target betamethasone maternal concentration and thus to optimize the antenatal dose to administer to the mother in the framework of Hyaline Membrane Disease.
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Number of neonates with hyaline membrane disease [ Time Frame: 3 days ]

respiratory symptoms (respiratory rhythm disorders, signs of retraction, cyanosis, oxgen dependance >30 %). Confirmation by radiology


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Genetic polymorphisms [ Time Frame: Day 1 ]
    To study the pharmacogenetics of genetic polymorphisms that may affect the placental transfer of steroids (CYP-3A4, CYP-3A5, P-glycoprotein)
  • mode of delivery [ Time Frame: Day 7 ]
    To study the variability of the factor " mode of delivery" on fetal morbidity
  • blood sample of betamethasone [ Time Frame: Day 1 and day 2 ]
    To study the pharmacokinetics of betamethasone in all women treated
  • Optimal dose of betamethasone [ Time Frame: Day 28 ]
    Determine the optimal dose of betamethasone necessary for the prevention of MMH, especially in infants under 28 weeks
  • gestational age [ Time Frame: Day 7 ]
    To study the variability of the factors "gestational age" on fetal morbidity
  • birth weight [ Time Frame: Day 7 ]
    To study the variability of the factor " birth weight" on fetal morbidity
  • sex [ Time Frame: Day 7 ]
    To study the variability of the factor "sex" on fetal morbidity
  • Apgar score [ Time Frame: Day 7 ]
    To study the variability of the factor " Apgar score " on fetal morbidity
  • twinning [ Time Frame: Day 7 ]
    To study the variability of the factors "twinning" on fetal morbidity
  • time between birth and the last dose [ Time Frame: Day 7 ]
    To study the variability of the factor "time between birth and the last dose" on fetal morbidity
  • ethnicity [ Time Frame: Day 7 ]
    To study the variability of the factor "ethnicity" on fetal morbidity
  • maternal disease and treatment [ Time Frame: Day 7 ]
    To study the variability of the factor " maternal disease and treatment on fetal morbidity


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: April 2, 2012
Date Started: January 2012
Date Completion: December 2018
Last Updated: August 23, 2016
Last Verified: August 2016