Controlled trial of dexamethasone in neonatal chronic lung disease: a 3-year follow-up.
OBJECTIVE
We compared the effects of a policy of neonatal steroid administration versus placebo for babies chronically dependent on supplemental oxygen in terms of long-term health and development, judged at 3 years of age.


METHODS
Double-blind randomized controlled trial.


METHODS
Thirty-one centers in the United Kingdom, Ireland, Belgium, Germany, Canada, and the United States.


METHODS
Babies who were chronically dependent on supplemental oxygen between 2 and 12 weeks of age were recruited to the trial between 1986 and 1989. Sixty-two children were known to have died, 23 before discharge from the hospital and 10 afterward in the active group, compared with 25 and 4, respectively, in the placebo group. Information was available for 209 of the 212 eligible for follow-up (99%).


METHODS
A 1-week course of active dexamethasone phosphate 0.6 mg/kg/d (dexamethasone base 0.5 mg/kg/d) or saline placebo was given intravenously (or orally, if no intravenous line). There was an option to give a second tapering 9-day course if relapse occurred after initial improvement.


METHODS
Information about respiratory problems, growth, neurodevelopment and disability, infection, and health service use when the children were 3 years old was ascertained from questionnaires to general practitioners, health visitors, and parents (and occasionally pediatricians).


RESULTS
About half the children in both groups had been admitted to the hospital for respiratory problems, with more in the active than the placebo group having at least five outpatient consultations for these problems over the 3 years. Overall, the children were below average in height, weight, and head circumference. About one fifth had cerebral palsy, 8% some visual loss, and 16% hearing loss; 18% needed or were anticipated to need special schooling. There were no clear differences between the randomized groups. These overall conclusions were not altered by any of the prespecified secondary analyses.


CONCLUSIONS
Despite early benefits, there were no clear effects at 3 years of age. As 40% of the placebo group eventually received open steroids, even a trial of this size has limited statistical power to detect a moderate effect of the policy. Regardless of random allocation, overall morbidity was high, confirming that babies with protracted dependence on supplemental oxygen are at high risk of childhood disability and poor health.
D002908:Chronic Disease; D002658:Developmental Disabilities / Q000453:epidemiology; D003907:Dexamethasone / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007234:Infant, Premature / Q000254:growth & development; D007235:Infant, Premature, Diseases / Q000188:drug therapy / Q000401:mortality; D008171:Lung Diseases / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D009422:Nervous System Diseases / Q000453:epidemiology; D010100:Oxygen / Q000627:therapeutic use; D016896:Treatment Outcome
D005938:Glucocorticoids; D003907:Dexamethasone; D010100:Oxygen