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Published on: May 4, 2020
Follow-up of a randomized, placebo-controlled trial of dexamethasone to decrease the duration of ventilator
T Michael O'Shea1, Lisa K Washburn, Patricia A Nixon
1Department of Pediatrics, Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA. moshea@wfubmc.edu
Insights
Dexamethasone in premature infants reduced chronic lung disease but showed higher rates of major neurodevelopmental impairments, including cerebral palsy, in long-term follow-up. However, the composite outcome of death or impairment was not significantly increased.
Area of Science:
- Neonatal medicine
- Pediatric neurology
- Developmental pediatrics
Background:
- High-dose dexamethasone use in premature infants is linked to reduced chronic lung disease.
- Concerns exist regarding potential developmental impairments associated with neonatal dexamethasone exposure.
Purpose of the Study:
- To evaluate long-term developmental outcomes in children exposed to dexamethasone as neonates.
- To compare neurodevelopmental impairments beyond infancy between dexamethasone and placebo groups.
Main Methods:
- A randomized trial assigned very low birth weight infants to a 42-day dexamethasone course or placebo.
- Survivors were assessed for major neurodevelopmental impairment (cerebral palsy, cognitive impairment, blindness) at 1 year and 4-11 years of age.
Main Results:
- Major neurodevelopmental impairments occurred in 40% of the dexamethasone group versus 20% in the placebo group, primarily due to increased cerebral palsy.
- The composite outcome of death or major neurodevelopmental impairment was 47% for dexamethasone and 41% for placebo.
Conclusions:
- A 42-day tapering course of dexamethasone does not increase the risk of the composite outcome of death or major neurodevelopmental impairment in very low birth weight infants.
- While dexamethasone use was associated with higher rates of specific impairments like cerebral palsy, the overall composite outcome was not significantly elevated in long-term follow-up.
Objective:
High doses of dexamethasone reduce the risk of chronic lung disease among premature infants but may increase the risk of developmental impairments. The objective of this study was to compare developmental outcomes beyond infancy for children who, as neonates, participated in a randomized trial of dexamethasone.
Patients And Methods:
One hundred eighteen children with birth weights <1500 g were randomly assigned at 15 to 25 days of life to a 42-day tapering course of dexamethasone or placebo. All 95 survivors were assessed by using standardized measures of developmental outcome at least once at or beyond 1 year of age, and 84 were examined at 4 to 11 years. For this follow-up study, the outcome of primary interest was death or major neurodevelopmental impairment, which was defined as cerebral palsy, cognitive impairment, or blindness.
Results:
On the basis of each child's most recent follow-up, the rates of major neurodevelopmental impairments were 40% for the dexamethasone group and 20% for the placebo group. The higher impairment rate for the dexamethasone group was mainly attributed to a higher prevalence of cerebral palsy. Rates of the composite outcome of death or major neurodevelopmental impairment were 47% and 41%, respectively.
Conclusion:
A 42-day tapering course of dexamethasone, which was shown previously to decrease the risk of chronic lung disease in very low birth weight infants, does not increase the risk of the composite outcome of death or major neurodevelopmental impairment.
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