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Completed

NCT Number: NCT00675246

Antenatal Corticoid Therapy for Late Preterm Babies

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.

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Key information

Conditions

Hyaline Membrane Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Death Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Perinatal Death Pregnancy Complications Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Tract Diseases Transient Tachypnea Urogenital Diseases

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Materno Infantil Prof. Fernando Figueira

Recife, Pernambuco, 50070550, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Betamethasone

Drug

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

Other names: CELESTONE SOLUSPAN (MANTECORP)

Primary outcomes

  1. neonatal respiratory distress

    Time frame: neonatal period (28 days of life)

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Instituto Materno Infantil Prof. Fernando Figueira

Other

Registry information

Official study title

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

Acronym: ACTLPT

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 9, 2008
Registry last updated
Jun 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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