Antenatal Corticoid Therapy for Late Preterm Babies

Hyaline Membrane Disease Clinical Trial

— ACTLPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00675246
• Other study ID #: CORTICOID001
• Status: Completed
• Phase: N/A
• First received: May 7, 2008
• Last updated: June 8, 2010
• Start date: May 2008
• Est. completion date: May 2010

Study information

• Verified date: June 2010
• Source: Instituto Materno Infantil Prof. Fernando Figueira
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hyaline Membrane Disease
• Transient Tachypnea

Intervention

Drug:
• Betamethasone
IM administration of 12mg of betamethasone each 24 hours (total dose=24mg)

Locations

Country	Name	City	State
Brazil	Instituto Materno Infantil Prof. Fernando Figueira	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Materno Infantil Prof. Fernando Figueira

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neonatal respiratory distress		neonatal period (28 days of life)	No
Secondary	during of neonatal hospitalization		neonatal period (28 days of life)	No
Secondary	neonatal oxygen requirement		neonatal period (28 days of life)	No
Secondary	neonatal sepsis		neonatal period (28 days of life)	No
Secondary	neonatal death		neonatal period (28 days of life)	No