Mid-Childhood Outcomes of Repeat Antenatal Corticosteroids: A Randomized Controlled Trial

Pediatrics. 2016 Oct;138(4):e20160947. doi: 10.1542/peds.2016-0947. Epub 2016 Sep 20.

Abstract

Objective: To assess if exposure to repeat dose(s) of antenatal corticosteroids has beneficial effects on neurodevelopment and general health in mid-childhood, at 6 to 8 years' corrected age.

Methods: Women at risk for very preterm birth, who had received a course of corticosteroids ≥7 days previously, were randomized to intramuscular betamethasone (11.4 mg Celestone Chronodose) or saline placebo, repeated weekly if risk of very preterm birth remained. Mid-childhood assessments included neurocognitive function, behavior, growth, lung function, blood pressure, health-related quality of life, and health service utilization. The primary outcome was survival free of neurosensory disability.

Results: Of the 1059 eligible long-term survivors, 963 (91%) were included in the primary outcome; 479 (91%) in the repeat corticosteroid group and 484 (91%) in the placebo group. The rate of survival free of neurosensory disability was similar in both groups (78.3% repeat versus 77.3% placebo; risk ratio 1.00, 95% confidence interval, 0.94-1.08). Neurodevelopment, including cognitive function, and behavior, body size, blood pressure, spirometry, and health-related quality of life were similar in both groups, as was the use of health services.

Conclusions: Treatment with repeat dose(s) of antenatal corticosteroids was associated with neither benefit nor harm in mid-childhood. Our finding of long-term safety supports the use of repeat dose(s) of antenatal corticosteroids, in view of the related neonatal benefits. For women at risk for preterm birth before 32 weeks' gestation, ≥7 days after an initial course of antenatal corticosteroids, clinicians could consider using a single injection of betamethasone, repeated weekly if risk remains.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Betamethasone / administration & dosage
  • Betamethasone / analogs & derivatives*
  • Blood Pressure
  • Body Size
  • Child
  • Child Behavior
  • Child Development
  • Cognition
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Glucocorticoids / administration & dosage*
  • Humans
  • Neuropsychological Tests
  • Pregnancy
  • Premature Birth / drug therapy*
  • Prenatal Care*
  • Quality of Life
  • Spirometry

Substances

  • Glucocorticoids
  • betamethasone acetate phosphate
  • Betamethasone

Associated data

  • ANZCTR/ACTRN12606000318583