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Antenatal Corticoid Therapy for Late Preterm Babies (ACTLPT)

This study has been completed.
Sponsor:
Information provided by:
Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier:
NCT00675246
First received: May 7, 2008
Last updated: June 8, 2010
Last verified: June 2010

May 7, 2008
June 8, 2010
May 2008
May 2010   (final data collection date for primary outcome measure)
neonatal respiratory distress [ Time Frame: neonatal period (28 days of life) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00675246 on ClinicalTrials.gov Archive Site
  • during of neonatal hospitalization [ Time Frame: neonatal period (28 days of life) ] [ Designated as safety issue: No ]
  • neonatal oxygen requirement [ Time Frame: neonatal period (28 days of life) ] [ Designated as safety issue: No ]
  • neonatal sepsis [ Time Frame: neonatal period (28 days of life) ] [ Designated as safety issue: No ]
  • neonatal death [ Time Frame: neonatal period (28 days of life) ] [ Designated as safety issue: No ]
  • during of neonatal hospitalization [ Time Frame: neonatal period (28 days of life) ] [ Designated as safety issue: No ]
  • neonatal oxygen requirement [ Time Frame: neonatal period (28 days of life) ] [ Designated as safety issue: No ]
  • neonatal sepsis [ Time Frame: neonatal period (28 days of life) ] [ Designated as safety issue: No ]
  • neonatal death [ Time Frame: neonatal period ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Antenatal Corticoid Therapy for Late Preterm Babies
Antenatal Corticoid Therapy for Fetal Lung Maturation in Late Preterm Pregnancies: a Randomized Controlled Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Hyaline Membrane Disease
  • Transient Tachypnea
Drug: Betamethasone
IM administration of 12mg of betamethasone each 24 hours (total dose=24mg)
Other Name: CELESTONE SOLUSPAN (MANTECORP)
Experimental: A
Antenatal corticoid therapy
Intervention: Drug: Betamethasone
Porto AM, Coutinho IC, Correia JB, Amorim MM. Effectiveness of antenatal corticosteroids in reducing respiratory disorders in late preterm infants: randomised clinical trial. BMJ. 2011 Apr 12;342:d1696. doi: 10.1136/bmj.d1696.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
320
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pregnancy between 34 and 36 weeks
  • Confirmed gestational age (LMP, USG)
  • Alive fetus
  • Imminent risk of preterm delivery

Exclusion Criteria:

  • Multiple pregnancy
  • Major fetal malformations
  • Comproved fetal lung maturity
  • Maternal or fetal indication for immediate interruption of pregnancy
  • Maternal hemorrhagic syndromes (placenta previa, abruptio placenta)
  • Chorioamnionitis
  • Chronic use of corticosteroids
  • Previous use of corticosteroids for fetal lung maturation in the current pregnancy
Female
18 Years to 49 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00675246
CORTICOID001
Yes
Ana Maria Feitosa Porto, Instituto Materno Infantil Prof. Fernando Figueira
Instituto Materno Infantil Prof. Fernando Figueira
Not Provided
Study Director: Melania Amorim, MD, PhD Instituto Materno Infantil Prof. Fernando Figueira
Instituto Materno Infantil Prof. Fernando Figueira
June 2010

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