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Melatonin supplementation for the treatment of infantile spasms: protocol for a randomised placebo-controlled
Yulin Sun1,2, Weiwei Feng3, Jian Chen2
1Department of Pediatrics, Medical School of Chinese PLA, Beijing, China.
Insights
This study investigates melatonin as a treatment for infantile spasms (IS), a severe infant epilepsy. Results will show if melatonin improves seizure control and development in infants with IS.
Area of Science:
- Pediatrics
- Neurology
- Pharmacology
Background:
- Infantile spasms (IS) is a severe epileptic encephalopathy in infants.
- IS is linked to sleep disorders and abnormal circadian rhythms, which can worsen spasms.
- Melatonin has anticonvulsant and neuroprotective effects, but its use in IS is understudied.
Purpose of the Study:
- To analyze the therapeutic effect of melatonin supplementation for infantile spasms treatment.
- To evaluate melatonin's impact on seizure frequency, response rate, and neurodevelopment in IS patients.
Main Methods:
- A triple-blinded, randomized controlled trial involving 70 infants (3 months to 2 years) with IS.
- Patients received standard treatment plus either melatonin or placebo.
- Outcomes assessed included seizure diaries, EEG, and developmental assessments over 2 weeks.
Main Results:
- Primary outcome: average reduced rate of spasms frequency after 2 weeks.
- Secondary outcomes: spasms-free rate, EEG hypsarrhythmia, psychomotor development (Denver Developmental Screening Test).
- Sleep quality and safety were also monitored.
Conclusions:
- This study will provide crucial data on melatonin's efficacy and safety for infantile spasms.
- Findings may lead to new therapeutic strategies for IS, potentially improving infant outcomes.
Introduction:
Infantile spasms (IS) is a type of severe epileptic encephalopathy that occurs in infancy and early childhood. IS is characterised clinically by epileptic spasms, often accompanied by sleep disorder and abnormal circadian rhythm. The endogenous circadian rhythm disorder, in turn, can make spasms worse. Melatonin has also been found to have anticonvulsant and neuroprotective properties by adjusting the circadian rhythm. However, there are lack of relevant studies on controlling IS by using melatonin. This study aims to analyse the therapeutic effect of melatonin supplementation for the treatment of IS.
Methods And Analysis:
This is a triple-blinded (trial participant, outcome assessor and the data analyst), prospective, randomised controlled trial to be conducted in the Department of Paediatrics, The First Medical Center of Chinese PLA General Hospital, Beijing, China from November 2020. Patients (n=70) aged 3 months to 2 years with IS will be recruited in this study after receiving written consent from their parents or guardians. Patients will be randomly divided into two equal groups and treated with a combination of adrenocorticotropic hormone, magnesium sulfate and either melatonin or placebo. Clinical data from the patients in the two groups before and after the treatment will be collected and compared. The primary outcome will be assessed 2 weeks later by seizure diaries and reported as the average reduced rate of spasms frequency. Secondary outcomes include the response rate (the rate of spasms-free), electroencephalogram hypsarrhythmia assessment and the psychomotor development assessment (Denver Developmental Screening Test). Sleep quality and safety will also be assessed.
Ethics And Dissemination:
The protocol for this study was approved by the Ethics Committee of Chinese PLA General Hospital (reference number S2020-337-01) and was reported according to the Standard Protocol Items: Recommendations for Interventional Trials statement. Findings of this research will be disseminated through national and international meetings, conferences and peer-reviewed journals.
Trial Registration Number:
ChiCTR2000036208.
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