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Published on: November 20, 2015
Neurocognitive outcomes at age 5 years after prophylactic hydrocortisone in infants born extremely preterm
Clémence Trousson1, Artemis Toumazi2, Aurélie Bourmaud2
1Assistance Publique-Hôpitaux de Paris, Neonatal Intensive Care Unit, Robert Debré Children's Hospital, Paris, France.
Insights
Prophylactic hydrocortisone in extremely preterm infants showed no significant difference in full-scale IQ at 5 years. However, it improved working memory and survival with IQ over 90, suggesting neurodevelopmental safety.
Area of Science:
- Neonatal Medicine
- Pediatric Neurology
- Clinical Trials
Background:
- Extremely preterm infants face risks of bronchopulmonary dysplasia and neurodevelopmental impairments.
- Prophylactic hydrocortisone has been explored to improve survival in this vulnerable population.
- Long-term neurocognitive outcomes following such interventions require thorough investigation.
Purpose of the Study:
- To evaluate the 5-year neurocognitive outcomes in children born extremely preterm who received prophylactic hydrocortisone.
- To assess the impact of hydrocortisone on cognitive development, including full-scale IQ, working memory, and retention ability.
- To determine the association between hydrocortisone treatment and survival with adequate neurocognitive function.
Main Methods:
- A secondary analysis of the PREMILOC clinical trial data was conducted.
- Neurocognitive outcomes were assessed at 5 years using the Wechsler Preschool and Primary Scale of Intelligence.
- Data from surviving infants in the hydrocortisone and placebo groups were compared using statistical analyses, including multivariate logistic regression.
Main Results:
- No significant difference in mean full-scale IQ was observed between the hydrocortisone (91.9) and placebo (86.3) groups.
- Infants treated with hydrocortisone demonstrated significantly better working memory and retention ability.
- Hydrocortisone treatment was associated with a significantly greater chance of survival with a full-scale IQ ≥ 90 (aOR=4.26, p=0.008).
Conclusions:
- Prophylactic hydrocortisone in extremely preterm infants appears neurodevelopmentally safe at 5-year follow-up.
- The intervention shows potential benefits for specific cognitive functions and survival with adequate IQ.
- These exploratory findings support further research into the long-term neurodevelopmental effects of early hydrocortisone exposure.
Aim:
To assess the 5-year neurocognitive outcomes of children born extremely preterm exposed to prophylactic hydrocortisone to improve survival without bronchopulmonary dysplasia.
Method:
This was a prespecified secondary analysis of the PREMILOC clinical trial (trial registration: EudraCT no. 2007-002041-20, NCT00623740). The primary outcome was full-scale IQ based on the Wechsler Preschool and Primary Scale of Intelligence.
Results:
Among 109 surviving children recruited at the Robert Debré Children's Hospital, Paris, outcome data were available for 42 out of 56 infants (75%) in the group treated with hydrocortisone and 41 out of 53 (77%) in the placebo group. Mean scores were not significantly different between the two groups on full-scale IQ (hydrocortisone: 91.9 [SD = 13.9], placebo: 86.3 [SD = 15.4]; mean difference = 5.7, 95% confidence interval [CI] = -1.0 to 12.3, p = 0.10); however, working memory and retention ability were significantly better in the group treated with hydrocortisone. In a multivariate logistic regression including potential confounding variables, hydrocortisone treatment was significantly associated with a greater chance to survive at 5 years of age with a full-scale IQ equal to or greater than 90 compared to placebo (adjusted odds ratio = 4.26, 95% CI = 1.47-12.36, p = 0.008).
Interpretation:
This exploratory analysis provides reassuring data regarding the long-term neurodevelopmental safety of prophylactic hydrocortisone in infants born extremely preterm.
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