PEDIATRICS Vol. 116 No. 2 August 2005, pp. 370-378 (doi:10.1542/peds.2004-1818)
Randomized, Controlled Trial of Dexamethasone in Neonatal Chronic Lung Disease: 13- to 17-Year Follow-up Study: I. Neurologic, Psychological, and Educational Outcomes
From the National Perinatal Epidemiology Unit, Oxford University, Oxford, United Kingdom
Objectives. To study neurologic, educational, and psychological status in adolescence of neonates enrolled in a double-blind, randomized, controlled trial of dexamethasone therapy for chronic lung disease.
Participants. A total of 287 infants who were chronically dependent on supplementary oxygen and were 2 to 12 weeks of age were recruited from 31 centers in 6 countries to a randomized, controlled trial of dexamethasone base (0.5 mg/kg per day for 1 week); 95% of survivors were reviewed at 3 years. Survivors from the 25 British and Irish centers were retraced at 13 to 17 years of age.
Outcome Measures. Nonverbal reasoning, British Picture Vocabulary Scale, Goodman Strengths and Difficulties Questionnaire behavior scores, school national test results, teacher ability ratings, and parental and general practitioner questionnaires.
Results. A total of 195 children were eligible for the follow-up study. Information was available for 150 children (77%), with 142 (73%) being assessed in home visits. No baseline differences were detected between the children included in the follow-up study and those not included. There was a slight excess of cerebral palsy in the steroid group, which was not statistically significant (relative risk: 1.58; 95% confidence interval: 0.81–3.07). Overall disability rates in both groups were high (21% moderate and 14% severe), but with no difference between the 2 groups (for severe disability, relative risk: 0.84; 95% confidence interval: 0.37–1.86).
Conclusions. Information was obtained for 150 adolescents randomized to receive dexamethasone or placebo for neonatal chronic lung disease. Rates of disabilities and educational difficulties were high, but with no significant differences between the 2 groups. Some use of open-label steroids in the placebo group plus losses to long-term follow-up monitoring reduced the power of this study to detect clinically important differences, and this study cannot rule out a real increase in cerebral palsy, as reported by others.
Key Words: neonatal chronic lung disease • dexamethasone therapy • randomized • controlled trial • developmental follow-up • school performance
Abbreviations: CLD, chronic lung disease • CP, cerebral palsy • GP, general practitioner • RR, relative risk • CI, confidence interval
Accepted Nov 19, 2004.
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