Abstract | AIM: 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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Authors | Clémence Trousson, Artemis Toumazi, Aurélie Bourmaud, Valérie Biran, Olivier Baud |
Journal | Developmental medicine and child neurology
(Dev Med Child Neurol)
Vol. 65
Issue 7
Pg. 926-932
(07 2023)
ISSN: 1469-8749 [Electronic] England |
PMID | 36417367
(Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | © 2022 Mac Keith Press. |
Chemical References |
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Topics |
- Child
- Child, Preschool
- Humans
- Infant
- Infant, Newborn
- Bronchopulmonary Dysplasia
(prevention & control, drug therapy)
- Hydrocortisone
(therapeutic use)
- Infant, Extremely Premature
- Logistic Models
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