Controlled trial of early dexamethasone treatment for the prevention of chronic lung disease in preterm infants: a 3-year follow-up

Pediatrics. 2002 Jun;109(6):e85. doi: 10.1542/peds.109.6.e85.

Abstract

Objective: There is increasing concern in regard to the possible long-term adverse effects of postnatal dexamethasone treatment in preterm infants. The purpose of this study was to assess growth and neurodevelopmental outcome in preterm infants at high risk of chronic lung disease (CLD), treated with early (<96 hours) postnatal dexamethasone.

Design: Three-year follow-up data of physical growth and neurodevelopmental outcome of preterm infants enrolled in a controlled trial to study the effectiveness of early postnatal dexamethasone administration for the prevention of CLD were reviewed. The original trial included 25 treated neonates who received dexamethasone intravenously from the fourth day of life for 7 days (0.5 mg/kg/d for the first 3 days, 0.25 mg/kg/d the next 3 days, and 0.125 mg/kg/d on the seventh day), and 25 untreated neonates as controls. Forty-five surviving infants (22 untreated and 23 treated) completed the 3-year follow-up.

Results: At the end of follow-up, infants pertaining to both study groups had similar values for body weight, height, and head circumference, and a similar incidence of infants with anthropometrics data below the third percentile. Moreover, no differences were detected between the groups in regard to incidence of major cranial ultrasound abnormalities, cerebral palsy, major neurosensory impairment or IQ scores, and distribution.

Conclusions: Early (<96 hours) postnatal dexamethasone administration at the doses employed in this study did not impair physical or neurodevelopmental outcome in preterm infants at high risk of CLD. However, the small sample size of our study was not tailored to look for long-term outcomes and our results are not in agreement with those of larger trials and systematic reviews. The real risks of postnatal dexamethasone administration could be definitely assessed only when more well-designed trials using long-term neurodevelopmental assessment as the primary outcome will be reported.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Anti-Inflammatory Agents / administration & dosage
  • Anti-Inflammatory Agents / pharmacology
  • Anti-Inflammatory Agents / therapeutic use*
  • Child Development / drug effects*
  • Child Development / physiology*
  • Child, Preschool
  • Chronic Disease
  • Confidence Intervals
  • Developmental Disabilities / prevention & control
  • Dexamethasone / administration & dosage
  • Dexamethasone / pharmacology
  • Dexamethasone / therapeutic use*
  • Drug Administration Schedule
  • Follow-Up Studies
  • Humans
  • Infant
  • Infant, Newborn
  • Infant, Premature, Diseases / drug therapy*
  • Lung Diseases / prevention & control*
  • Odds Ratio
  • Outcome Assessment, Health Care
  • Patient Readmission

Substances

  • Anti-Inflammatory Agents
  • Dexamethasone