Antenatal Corticoid Therapy for Late Preterm Babies
ACTLPT
1 other identifier
interventional
320
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 7, 2008
CompletedFirst Posted
Study publicly available on registry
May 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedJune 9, 2010
June 1, 2010
2 years
May 7, 2008
June 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
neonatal respiratory distress
neonatal period (28 days of life)
Secondary Outcomes (4)
during of neonatal hospitalization
neonatal period (28 days of life)
neonatal oxygen requirement
neonatal period (28 days of life)
neonatal sepsis
neonatal period (28 days of life)
neonatal death
neonatal period (28 days of life)
Study Arms (1)
A
EXPERIMENTALAntenatal corticoid therapy
Interventions
IM administration of 12mg of betamethasone each 24 hours (total dose=24mg)
Eligibility Criteria
You may qualify if:
- Pregnancy between 34 and 36 weeks
- Confirmed gestational age (LMP, USG)
- Alive fetus
- Imminent risk of preterm delivery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Materno Infantil Prof. Fernando Figueira
Recife, Pernambuco, 50070550, Brazil
Related Publications (1)
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.
PMID: 21487057DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Melania Amorim, MD, PhD
Instituto Materno Infantil Prof. Fernando Figueira
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 7, 2008
First Posted
May 9, 2008
Study Start
May 1, 2008
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
June 9, 2010
Record last verified: 2010-06