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Antenatal Corticoid Therapy for Late Preterm Babies

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00675246
Acronym
ACTLPT
Enrollment
320
Registered
2008-05-09
Start date
2008-05-31
Completion date
2010-05-31
Last updated
2010-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyaline Membrane Disease, Transient Tachypnea

Keywords

corticoid therapy, fetal lung maturation, late preterm, respiratory distress syndrome, neonatal death

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 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.

Interventions

DRUGBetamethasone

IM administration of 12mg of betamethasone each 24 hours (total dose=24mg)

Sponsors

Instituto Materno Infantil Prof. Fernando Figueira
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
neonatal respiratory distressneonatal period (28 days of life)

Secondary

MeasureTime frame
neonatal deathneonatal period (28 days of life)
during of neonatal hospitalizationneonatal period (28 days of life)
neonatal oxygen requirementneonatal period (28 days of life)
neonatal sepsisneonatal period (28 days of life)

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026