Trial of early neonatal hydrocortisone: two-year follow-up

Neonatology. 2009;95(3):240-7. doi: 10.1159/000164150. Epub 2008 Oct 17.

Abstract

Background: Dexamethasone treatment is associated with an increased risk of cerebral palsy (CP). Early hydrocortisone (HC) treatment may decrease the incidence of bronchopulmonary dysplasia; however, the long-term effects are still under evaluation. Follow-up of randomized studies concerning early HC treatment is essential to confirm the long-term safety.

Objective: We hypothesized that early HC treatment in very preterm infants does not impair the neurologic outcome.

Methods: We report follow-up data from a randomized trial of early HC given for 10 days. Before the HC or placebo treatment, serum cortisol levels were measured. Receiver-operating characteristic was defined. Values below the median were classified as low endogenous cortisol and those above the median as high endogenous cortisol. A meta-analysis was performed.

Results: Altogether 98% of the 46 surviving infants participated in a follow-up study at a corrected age of 2 years. The growth characteristics were similar between the study groups. The developmental quotients (DQs) of the children with high endogenous cortisol and placebo treatment shortly after birth (100 +/- 13) and those with low endogenous cortisol and HC (97 +/- 7) were not lower than the DQs of the children with high endogenous cortisol and HC (92 +/- 3) or low cortisol and placebo (96 +/- 2). According to a meta-analysis of three available trials (411 children), the rate of CP and survival without neurosensory or cognitive impairment was not influenced by HC.

Conclusion: Early low-dose HC administration had no adverse effects at 2 years of age. Further studies are required to define the target group for neonatal HC.

Publication types

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

MeSH terms

  • Anti-Inflammatory Agents / adverse effects
  • Anti-Inflammatory Agents / therapeutic use*
  • Bronchopulmonary Dysplasia / blood
  • Bronchopulmonary Dysplasia / drug therapy*
  • Child Development / drug effects*
  • Child Development / physiology
  • Child, Preschool
  • Female
  • Growth / drug effects
  • Humans
  • Hydrocortisone / adverse effects
  • Hydrocortisone / blood
  • Hydrocortisone / therapeutic use*
  • Infant, Newborn
  • Male
  • Meta-Analysis as Topic
  • Predictive Value of Tests
  • ROC Curve
  • Respiratory Distress Syndrome, Newborn / blood
  • Respiratory Distress Syndrome, Newborn / drug therapy*

Substances

  • Anti-Inflammatory Agents
  • Hydrocortisone