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Melatonin for sleep disorders in children with neurodevelopmental disorders: protocol for a systematic review with

Caroline Kamp Jørgensen^1,2, Rikke Hermann^3,4, Sophie Juul³

¹Copenhagen Trial Unit, Centre for Clinical Intervention Research, Capital Region of Denmark, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark caroline.joergensen@ctu.dk.

|November 29, 2022

Insights

This systematic review will assess melatonin's effectiveness and safety for sleep issues in children with neurodevelopmental disorders. It aims to provide reliable evidence on sleep duration, quality of life, and adverse effects, addressing limitations of previous studies.

Area of Science:

Neuroscience
Pediatrics
Pharmacology

Background:

Neurodevelopmental disorders (NDDs) are frequently associated with sleep disturbances, impacting child and family well-being.
Melatonin is a common intervention for sleep disorders in children with NDDs.
Previous reviews on melatonin for NDDs have limitations, including insufficient adverse effect analysis and small sample sizes.

Purpose of the Study:

To conduct a systematic review and meta-analysis of randomized clinical trials on melatonin for sleep disorders in children with NDDs.
To evaluate the efficacy and safety of melatonin, including total sleep time, sleep onset latency, and adverse effects.
To assess the impact of melatonin on the quality of life for children with NDDs and their caregivers.

Main Methods:

Systematic review and meta-analysis with Trial Sequential Analysis of randomized clinical trials.
Comprehensive literature search across multiple databases (e.g., Cochrane, MEDLINE, Embase, PsycINFO) and clinical trial registries.
Inclusion of trials comparing melatonin to placebo or no intervention; data extraction and risk of bias assessment by paired reviewers.

Main Results:

Primary outcomes include total sleep time and adverse effects.
Secondary outcomes encompass quality of life and sleep onset latency.
Data will be analyzed using both random-effects and fixed-effect meta-analyses.

Conclusions:

This rigorous systematic review will provide updated, high-certainty evidence on melatonin's use in pediatric NDDs.
Findings will inform clinical practice and guidelines regarding melatonin for sleep disorders in this population.
The study aims to overcome limitations of prior research by incorporating Trial Sequential Analysis and comprehensive adverse event reporting.

Read full analysis

Abstract

Introduction:

Neurodevelopmental disorders are a group of disorders thought to be associated with the functioning of the brain and the nervous system. Children with neurodevelopmental disorders often have sleep-related comorbidities that may negatively affect quality of life for both the children and their families. Melatonin is one of the most used interventions in children with neurodevelopmental disorders and sleep disorders. Previous reviews have investigated the effects of melatonin for sleep disorders in children with neurodevelopmental disorders, but these had important limitations, such as inadequate analysis of adverse effects, small sample sizes and short follow-up.

Methods And Analysis:

This is a protocol for a systematic review with meta-analysis and Trial Sequential Analysis of randomised clinical trials. The protocol is reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols. We will search for published and unpublished trials in the Cochrane Central Register of Controlled Trials, MEDLINE Ovid, Embase Ovid, LILACS, Science Citation Index Expanded, Conference Proceedings Citation Index-Science, PsycINFO, ClinicalTrials.gov and the International Clinical Trials Registry Platform. We will search the databases from their inception without language restrictions. We will also request clinical study reports from regulatory authorities and pharmaceutical companies. Review authors working in pairs will screen reports, extract data and conduct risk of bias assessments using the Cochrane Risk of Bias tool. We will include randomised clinical trials comparing melatonin versus placebo or no intervention for sleep disorders in children with neurodevelopmental disorders. Primary outcomes will be total sleep time and adverse effects. Secondary outcomes will be quality of life of the child and caregivers and sleep onset latency. Data will be analysed using random-effects and fixed-effect meta-analyses. Certainty of evidence will be assessed with Grading of Recommendations, Assessment, Development and Evaluation approach.

Ethics And Dissemination:

Ethical approval was not required for this protocol. The systematic review will be published in a peer-reviewed journal.

Prospero Registration Number:

CRD42022337530.

Keywords:

Developmental neurology & neurodisability Paediatric neurology SLEEP MEDICINE

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