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Trial record 81 of 272 for:    Betamethasone

Antenatal Corticoid Therapy for Late Preterm Babies (ACTLPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00675246
Recruitment Status : Completed
First Posted : May 9, 2008
Last Update Posted : June 9, 2010
Information provided by:
Instituto Materno Infantil Prof. Fernando Figueira

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.

Condition or disease Intervention/treatment Phase
Hyaline Membrane Disease Transient Tachypnea Drug: Betamethasone Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Antenatal Corticoid Therapy for Fetal Lung Maturation in Late Preterm Pregnancies: a Randomized Controlled Trial
Study Start Date : May 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Arm Intervention/treatment
Experimental: A
Antenatal corticoid therapy
Drug: Betamethasone
IM administration of 12mg of betamethasone each 24 hours (total dose=24mg)

Primary Outcome Measures :
  1. neonatal respiratory distress [ Time Frame: neonatal period (28 days of life) ]

Secondary Outcome Measures :
  1. during of neonatal hospitalization [ Time Frame: neonatal period (28 days of life) ]
  2. neonatal oxygen requirement [ Time Frame: neonatal period (28 days of life) ]
  3. neonatal sepsis [ Time Frame: neonatal period (28 days of life) ]
  4. neonatal death [ Time Frame: neonatal period (28 days of life) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00675246

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ana Maria Feitosa Porto, Instituto Materno Infantil Prof. Fernando Figueira Identifier: NCT00675246     History of Changes
Other Study ID Numbers: CORTICOID001
First Posted: May 9, 2008    Key Record Dates
Last Update Posted: June 9, 2010
Last Verified: June 2010
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:
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Betamethasone Valerate
Betamethasone benzoate
Betamethasone sodium phosphate
Hyaline Membrane Disease
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiratory Distress Syndrome, Newborn
Lung Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents