Antenatal Corticoid Therapy for Late Preterm Babies (ACTLPT)

June 8, 2010 updated by: Instituto Materno Infantil Prof. Fernando Figueira

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50070550
        • Instituto Materno Infantil Prof. Fernando Figueira

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
Antenatal corticoid therapy
Drug: Betamethasone
IM administration of 12mg of betamethasone each 24 hours (total dose=24mg)
Other Names:
  • CELESTONE SOLUSPAN (MANTECORP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
neonatal respiratory distress
Time Frame: neonatal period (28 days of life)
neonatal period (28 days of life)

Secondary Outcome Measures

Outcome Measure
Time Frame
during of neonatal hospitalization
Time Frame: neonatal period (28 days of life)
neonatal period (28 days of life)
neonatal oxygen requirement
Time Frame: neonatal period (28 days of life)
neonatal period (28 days of life)
neonatal sepsis
Time Frame: neonatal period (28 days of life)
neonatal period (28 days of life)
neonatal death
Time Frame: neonatal period (28 days of life)
neonatal period (28 days of life)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Materno Infantil Prof. Fernando Figueira

Investigators

  • Study Director: Melania Amorim, MD, PhD, Instituto Materno Infantil Prof. Fernando Figueira

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

May 7, 2008

First Submitted That Met QC Criteria

May 8, 2008

First Posted (ESTIMATE)

May 9, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 9, 2010

Last Update Submitted That Met QC Criteria

June 8, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CORTICOID001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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