Journal Article

Neurodevelopmental Outcomes of Extremely Preterm Infants Randomized to Stress Dose Hydrocortisone

Tyson, Jon E., Kennedy, Kathleen A., Parikh, Nehal A., Lasky, Robert E.

2015

Overview

To compare the effects of stress dose hydrocortisone therapy with placebo on survival without neurodevelopmental impairments in high-risk preterm infants. We recruited 64 extremely low birth weight (birth weight ≤1000 g) infants between the ages of 10 and 21 postnatal days who were ventilator-dependent and at high-risk for bronchopulmonary dysplasia. Infants were randomized to a tapering 7-day course of stress dose hydrocortisone or saline placebo. The primary outcome at follow-up was a composite of death, cognitive or language delay, cerebral palsy, severe hearing loss, or bilateral blindness at a corrected age of 18-22 months. Secondary outcomes included continued use of respiratory therapies and somatic growth. Fifty-seven infants had adequate data for the primary outcome. Of the 28 infants randomized to hydrocortisone, 19 (68%) died or survived with impairment compared with 22 of the 29 infants (76%) assigned to placebo (relative risk: 0.83; 95% CI, 0.61 to 1.14). The rates of death for those in the hydrocortisone and placebo groups were 31% and 41%, respectively (P = 0.42). Randomization to hydrocortisone also did not significantly affect the frequency of supplemental oxygen use, positive airway pressure support, or need for respiratory medications. In high-risk extremely low birth weight infants, stress dose hydrocortisone therapy after 10 days of age had no statistically significant effect on the incidence of death or neurodevelopmental impairment at 18-22 months. These results may inform the design and conduct of future clinical trials. ClinicalTrials.gov NCT00167544.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Age / Babies / Birth weight / Blindness / Brain research / Care and treatment / Cerebral palsy / Clinical trials / Cognitive ability / Death / Development and progression / Dose-Response Relationship, Drug / Drug dosages / Dysplasia / Evidence-based medicine / Female / Health aspects / Hearing impairment / Hearing loss / Hospitals / Humans / Hydrocortisone / Hydrocortisone - adverse effects / Hydrocortisone - pharmacology / Impairment / Infant / Infant, Extremely Premature - growth & development / Infant, Extremely Premature - physiology / Infant, Newborn / Infants / Intensive care / Low birth weight / Lung diseases / Male / Medical research / Medical schools / Medicine / Mortality / Nervous System - drug effects / Nervous System - growth & development / Neurodevelopmental disorders / Newborn babies / Oxygen / Paralysis / Patient outcomes / Pediatrics / Pregnancy / Premature babies / Premature infants / Randomization / Respiratory tract / Risk / Risk factors / Safety / Statistical analysis / Steroids / Stress, Physiological - drug effects / Stresses / Survival Analysis / Tapering / Therapy / Ventilators