Clinical Trial: Antenatal Corticoid Therapy for Late Preterm Babies

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Antenatal Corticoid Therapy for Fetal Lung Maturation in Late Preterm Pregnancies: a Randomized Controlled Trial

Brief Summary: This study aims to determine the effectiveness of antenatal corticosteroid therapy in late preterm babies. The investigators hypothesis is corticoid accelerates fetal lung maturation even after 34 weeks and reduces risk of respiratory distress syndrome and other neonatal morbidities.

Detailed Summary: Late preterm babies have important morbidity when compared with term babies, with oxygen requirement and more days of hospitalization. If antenatal corticosteroid therapy is necessary for fetal lung maturation after 34 weeks, it remains to be established. The systematic review with metanalysis in Cochrane Library includes a small number of late preterm babies and no conclusion about effectiveness of corticoid therapy in this setting could be drawn. Our hypothesis is that antenatal corticosteroid therapy is effective to prevent respiratory disease and morbidity in late preterm babies and this study will be carried out to evaluate this question.
Sponsor: Instituto Materno Infantil Prof. Fernando Figueira

Current Primary Outcome: neonatal respiratory distress [ Time Frame: neonatal period (28 days of life) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • during of neonatal hospitalization [ Time Frame: neonatal period (28 days of life) ]
  • neonatal oxygen requirement [ Time Frame: neonatal period (28 days of life) ]
  • neonatal sepsis [ Time Frame: neonatal period (28 days of life) ]
  • neonatal death [ Time Frame: neonatal period (28 days of life) ]


Original Secondary Outcome:

  • during of neonatal hospitalization [ Time Frame: neonatal period (28 days of life) ]
  • neonatal oxygen requirement [ Time Frame: neonatal period (28 days of life) ]
  • neonatal sepsis [ Time Frame: neonatal period (28 days of life) ]
  • neonatal death [ Time Frame: neonatal period ]


Information By: Instituto Materno Infantil Prof. Fernando Figueira

Dates:
Date Received: May 7, 2008
Date Started: May 2008
Date Completion:
Last Updated: June 8, 2010
Last Verified: June 2010