Clinical trial NCT00675246: Antenatal Corticoid Therapy for Late Preterm Babies
Official title: Antenatal Corticoid Therapy for Fetal Lung Maturation in Late Preterm Pregnancies: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyaline Membrane Disease
Transient Tachypnea
Keywords: corticoid therapy
fetal lung maturation
late preterm
respiratory distress syndrome
neonatal death
Lead sponsor: Instituto Materno Infantil Prof. Fernando Figueira
Sponsor class: OTHER
First posted: 2008-05-09
Enrollment: 320
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: neonatal respiratory distress
timeFrame: neonatal period (28 days of life)
Secondary outcomes:
measure: during of neonatal hospitalization
timeFrame: neonatal period (28 days of life)
measure: neonatal oxygen requirement
timeFrame: neonatal period (28 days of life)
measure: neonatal sepsis
timeFrame: neonatal period (28 days of life)
measure: neonatal death
timeFrame: neonatal period (28 days of life)
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Instituto Materno Infantil Prof. Fernando Figueira
state: Pernambuco
Study officials:
affiliation: Instituto Materno Infantil Prof. Fernando Figueira
name: Melania Amorim, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.