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Antenatal Corticoid Therapy for Late Preterm Babies (ACTLPT)

Primary Purpose

Hyaline Membrane Disease, Transient Tachypnea

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Betamethasone

About this trial

This is an interventional prevention trial for Hyaline Membrane Disease focused on measuring corticoid therapy, fetal lung maturation, late preterm, respiratory distress syndrome, neonatal death

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Instituto Materno Infantil Prof. Fernando Figueira

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Antenatal corticoid therapy

Outcomes

Primary Outcome Measures

neonatal respiratory distress

Secondary Outcome Measures

during of neonatal hospitalization

neonatal oxygen requirement

neonatal sepsis

neonatal death

Full Information

NCT ID

NCT00675246

First Posted

May 7, 2008

Last Updated

June 8, 2010

Sponsor

Instituto Materno Infantil Prof. Fernando Figueira

1. Study Identification

Unique Protocol Identification Number

NCT00675246

Brief Title

Antenatal Corticoid Therapy for Late Preterm Babies

Acronym

ACTLPT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2010

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Instituto Materno Infantil Prof. Fernando Figueira

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyaline Membrane Disease, Transient Tachypnea

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Antenatal corticoid therapy

Intervention Type

Drug

Intervention Name(s)

Betamethasone

Other Intervention Name(s)

CELESTONE SOLUSPAN (MANTECORP)

Intervention Description

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

Primary Outcome Measure Information:

Title

neonatal respiratory distress

Time Frame