1. Controlled trial of dexamethasone on neonatal chronic lung disease: a 3-year follow-up
- Author
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Jones, Rosamond, Wincott, Elizabeth, Elbourne, Diana, and Grant, Adrian
- Subjects
Dexamethasone -- Evaluation ,Bronchopulmonary dysplasia -- Drug therapy ,Infants (Newborn) -- Care and treatment ,Respiratory therapy for newborn infants -- Health aspects - Abstract
Administering dexamethasone to premature newborns with breathing difficulties does not appear to confer long-term benefits. Dexamethasone has been shown to reduce the need for mechanical ventilation during the newborn period. Researchers evaluated the outcomes of 209 children at age three who, as newborns, had been randomly assigned to receive dexamethasone to treat breathing difficulty or a saline placebo. The average gestational age of the group was 27 weeks and the average birth weight was 1000 gm. No differences were found in death rates from respiratory failure between hospital discharge and age three, or in the percentages with respiratory problems, impaired growth, neurologic deficits, infection rates, or the use of health services. However, the design of the trial permitted administration of dexamethasone if the infants' conditions was deteriorating, and 40% of the saline group actually received dexamethasone., 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. Design. Double-blind randomized controlled trial. Setting. Thirty-one centers in the United Kingdom, Ireland, Belgium, Germany, Canada, and the United States. Patients. 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%). Interventions. 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. Outcome Measures. 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., Neonatal chronic lung disease is a well-recognized complication of preterm birth associated with increased mortality and morbidity, not only in the early weeks but also continuing after discharge from the [...]
- Published
- 1995