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Antenatal Corticoid Therapy for Late Preterm Babies (ACTLPT)

This study has been completed.
Sponsor:
Information provided by:
Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier:
NCT00675246
First received: May 7, 2008
Last updated: June 8, 2010
Last verified: June 2010
History of Changes
  Purpose

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.


Condition Intervention
Hyaline Membrane Disease
Transient Tachypnea
 Drug: Betamethasone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Antenatal Corticoid Therapy for Fetal Lung Maturation in Late Preterm Pregnancies: a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto Materno Infantil Prof. Fernando Figueira:

Primary Outcome Measures:
  • neonatal respiratory distress [ Time Frame: neonatal period (28 days of life) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • during of neonatal hospitalization [ Time Frame: neonatal period (28 days of life) ] [ Designated as safety issue: No ]
  • neonatal oxygen requirement [ Time Frame: neonatal period (28 days of life) ] [ Designated as safety issue: No ]
  • neonatal sepsis [ Time Frame: neonatal period (28 days of life) ] [ Designated as safety issue: No ]
  • neonatal death [ Time Frame: neonatal period (28 days of life) ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: May 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Antenatal corticoid therapy
 Drug: Betamethasone
IM administration of 12mg of betamethasone each 24 hours (total dose=24mg)
Other Name: CELESTONE SOLUSPAN (MANTECORP)

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

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00675246

Locations
Brazil
Instituto Materno Infantil Prof. Fernando Figueira
Recife, Pernambuco, Brazil, 50070550
Sponsors and Collaborators
Instituto Materno Infantil Prof. Fernando Figueira
Investigators
Study Director: Melania Amorim, MD, PhD Instituto Materno Infantil Prof. Fernando Figueira
  More Information

No publications provided by Instituto Materno Infantil Prof. Fernando Figueira

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ana Maria Feitosa Porto, Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier: NCT00675246     History of Changes
Other Study ID Numbers: CORTICOID001
Study First Received: May 7, 2008
Last Updated: June 8, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Instituto Materno Infantil Prof. Fernando Figueira:
corticoid therapy
fetal lung maturation
late preterm
respiratory distress syndrome
neonatal death

Additional relevant MeSH terms:
Hyaline Membrane Disease
Respiratory Distress Syndrome, Newborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone acetate phosphate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
 Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013