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Controlled trial of dexamethasone in neonatal chronic lung disease: a 3-year follow-up
R Jones1, E Wincott, D Elbourne
1Department of Pediatrics, Wrexham Park Hospital, United Kingdom.
Insights
Neonatal steroid administration did not show clear long-term benefits for oxygen-dependent infants at three years. High overall morbidity highlights the risks for these vulnerable infants.
Area of Science:
- Neonatal care
- Pediatric pulmonology
- Clinical pharmacology
Background:
- Infants requiring chronic supplemental oxygen face significant long-term health and developmental challenges.
- The efficacy of early steroid administration in mitigating these risks remains an important clinical question.
Purpose of the Study:
- To compare the long-term health and developmental outcomes at 3 years of age in infants receiving neonatal steroids versus placebo.
- To evaluate the impact of a policy of neonatal steroid administration on outcomes for oxygen-dependent infants.
Main Methods:
- A double-blind, randomized controlled trial involving 31 centers across multiple countries.
- Recruitment of infants dependent on supplemental oxygen between 2 and 12 weeks of age.
- Administration of a 1-week course of dexamethasone phosphate or saline placebo, with an option for a second tapering course.
Main Results:
- No clear differences were observed between the steroid and placebo groups at 3 years of age regarding growth, neurodevelopment, or disability.
- Children in both groups exhibited high rates of respiratory problems, with more outpatient consultations in the active group.
- Significant rates of cerebral palsy, visual impairment, hearing loss, and need for special schooling were noted across all participants.
Conclusions:
- Early benefits of neonatal steroids were not sustained at 3 years, with no clear long-term effects on health or development.
- The study's statistical power was limited due to a high crossover rate to open steroid use in the placebo group.
- Protracted oxygen dependence in infancy is associated with high overall morbidity and risk of childhood disability, irrespective of early steroid treatment.
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.