Effect of intramuscular ACTH versus oral prednisolone on the developmental trajectories of children with West syndrome over 24 months: A randomised control study.

Autor: Sumanasena SP; Paediatric Disabilities and Consultant Paediatrician, Postal address Department of Disability Studies Faculty of Medicine University of Kelaniya, P.O. Box 6, Thalagolla Road, Ragama Sri Lanka. Electronic address: samanmali@kln.ac.lk., Wanigasinghe J; Paediatrics and Specialist Pediatric Neurologist, Postal address Department of Paediatrics Faculty of Medicine University of Colombo, No. 25, Kynsey Road, Colombo 08, Sri Lanka. Electronic address: jithangi@gmail.com., Arambepola C; Community Medicine and Specialist in Community Medicine, Postal address Department of Community Medicine Faculty of Medicine University of Colombo, No. 25, Kynsey Road, Colombo 08, Sri Lanka. Electronic address: carukshi@yahoo.com., Sri Ranganathan S; Pharmacology and Specialist in Paediatrics, Department of Pharmacology, Faculty of Medicine University of Colombo, No. 25, Kynsey Road, Colombo 08, Sri Lanka. Electronic address: sshalini14@hotmail.com., Muhandiram E; Department of Paediatrics, Faculty of Medicine University of Colombo, No. 25, Kynsey Road, Colombo 08, Sri Lanka. Electronic address: eindrinimec@gmail.com.
Jazyk: angličtina
Zdroj: European journal of paediatric neurology : EJPN : official journal of the European Paediatric Neurology Society [Eur J Paediatr Neurol] 2021 May; Vol. 32, pp. 98-105. Date of Electronic Publication: 2021 Apr 14.
DOI: 10.1016/j.ejpn.2021.04.003
Abstrakt: Objective: To assess the developmental progression and compare the developmental attainments of children treated with two hormonal therapies for infantile spasms (IS) over two years (seizure and EEG outcomes of this RCT published previously).
Methods: Newly diagnosed infants with IS were randomised to receive adrenocorticotrophin (ACTH) or prednisolone for 14 days. All underwent Bayley III Infant and Toddler Assessments in cognitive (Cog), receptive (RC) and expressive (EC) communication, fine (FM) and gross (GM) motor developmental subsets at baseline (T0), one-year (T1) and two-years (T2).
Results: 95 infants randomised to prednisolone (n = 48) and ACTH (n = 47) groups were eligible for developmental assessments. Mean age at initial assessment was 8.75 months (SD = 6.37, range 1.46-34.4 months). 48 children presented for all three assessments. Mean composite scores of each developmental domain improved across the three time points; but the progression was significant only in relation to motor development (p = 0.04). When comparing the treatment outcomes at 2-years, mean composite scores of children treated with ACTH were significantly lower in motor domain (p = 0.023). As for developmental delay, the ACTH group (n = 32) showed significant delay in expressive communication (adjusted OR 5.46, 95% CI: 1.1, 28.57; p = 0.04) and fine motor (adjusted OR 9.4, 95% CI: 1.1, 83.3; p = 0.04) at T2 compared to the prednisolone (n = 30) in a regression analysis.
Conclusion: The number of children with delay at the 2 year follow up were significantly higher in two domains in the ACTH group compared to the prednisolone group. Overall results do not show a significant advantage of ACTH over prednisolone for developmental outcomes at two years, but further comparative studies over longer periods are required for more definitive conclusions.
Competing Interests: Declaration of competing interest None of the authors have any conflicts of interests with the content in this paper. We have not obtained any payments, funding or goods from any person or organization involved with the content of this paper. Partial funding for this study was received from the Sri Lanka Medical Association as a research grant.
(Copyright © 2021 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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