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Trial of early neonatal hydrocortisone: two-year follow-up
Outi M Peltoniemi1, Aulikki Lano, Riina Puosi
1Department of Pediatrics, University of Oulu, Oulu, Finland. outi.peltoniemi@mail.suomi.net
Insights
Early hydrocortisone (HC) treatment in preterm infants showed no adverse neurologic outcomes at 2 years. This study confirms the safety of HC for infants, with no increased risk of cerebral palsy.
Area of Science:
- Neonatal care and developmental pediatrics.
- Pharmacological interventions in premature infants.
Background:
- Dexamethasone use in neonates is linked to increased cerebral palsy (CP) risk.
- Early hydrocortisone (HC) may reduce bronchopulmonary dysplasia but requires long-term safety evaluation.
- Confirming the long-term safety of early HC treatment in preterm infants is crucial.
Purpose of the Study:
- To investigate the hypothesis that early hydrocortisone (HC) treatment does not negatively impact neurologic outcomes in very preterm infants.
- To assess the long-term safety and neurodevelopmental effects of early HC administration.
Main Methods:
- Follow-up data from a randomized trial of 10-day early HC or placebo treatment.
- Measurement of serum cortisol levels pre-treatment to classify infants as low or high endogenous cortisol.
- Meta-analysis of three trials involving 411 infants to evaluate CP rates and neurodevelopmental outcomes.
Main Results:
- 98% of surviving infants (46) attended a 2-year follow-up; growth characteristics were similar across groups.
- Developmental quotients (DQs) at 2 years were comparable between HC and placebo groups, regardless of endogenous cortisol levels.
- Meta-analysis indicated no significant influence of HC on CP rates or survival without neurosensory/cognitive impairment.
Conclusions:
- Early low-dose hydrocortisone (HC) administration demonstrated no adverse effects on neurodevelopment at 2 years of corrected age.
- Findings support the safety of early HC treatment in very preterm infants.
- Further research is needed to identify specific infant populations who may benefit most from neonatal HC.
Background:
Dexamethasone treatment is associated with an increased risk of cerebral palsy (CP). Early hydrocortisone (HC) treatment may decrease the incidence of bronchopulmonary dysplasia; however, the long-term effects are still under evaluation. Follow-up of randomized studies concerning early HC treatment is essential to confirm the long-term safety.
Objective:
We hypothesized that early HC treatment in very preterm infants does not impair the neurologic outcome.
Methods:
We report follow-up data from a randomized trial of early HC given for 10 days. Before the HC or placebo treatment, serum cortisol levels were measured. Receiver-operating characteristic was defined. Values below the median were classified as low endogenous cortisol and those above the median as high endogenous cortisol. A meta-analysis was performed.
Results:
Altogether 98% of the 46 surviving infants participated in a follow-up study at a corrected age of 2 years. The growth characteristics were similar between the study groups. The developmental quotients (DQs) of the children with high endogenous cortisol and placebo treatment shortly after birth (100 +/- 13) and those with low endogenous cortisol and HC (97 +/- 7) were not lower than the DQs of the children with high endogenous cortisol and HC (92 +/- 3) or low cortisol and placebo (96 +/- 2). According to a meta-analysis of three available trials (411 children), the rate of CP and survival without neurosensory or cognitive impairment was not influenced by HC.
Conclusion:
Early low-dose HC administration had no adverse effects at 2 years of age. Further studies are required to define the target group for neonatal HC.
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