Evidence map›Paper›PMID 36446459›Full record

ArticleBMJ open2022

Melatonin for sleep disorders in children with neurodevelopmental disorders: protocol for a systematic review with meta-analysis and Trial Sequential Analysis of randomised clinical trials.

Caroline Kamp Jørgensen, Rikke Hermann, Sophie Juul, Pascal Faltermeier, Mark Horowitz, Joanna Moncrieff, Christian Gluud, Janus Christian Jakobsen

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.1field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 3 countries.

Caroline Kamp JørgensenCopenhagen Trial Unit, Centre for Clinical Intervention Research, Capital Region of Denmark, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark caroline.joergensen@ctu.dk.ORCID 0000-0002-7756-4694
Rikke HermannCopenhagen Trial Unit, Centre for Clinical Intervention Research, Capital Region of Denmark, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Sophie JuulCopenhagen Trial Unit, Centre for Clinical Intervention Research, Capital Region of Denmark, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Pascal FaltermeierCopenhagen Trial Unit, Centre for Clinical Intervention Research, Capital Region of Denmark, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Mark HorowitzResearch and Development Department, North East London NHS Foundation Trust (NELFT), London, UK.
Joanna MoncrieffResearch and Development Department, North East London NHS Foundation Trust (NELFT), London, UK.ORCID 0000-0003-1214-6974
Christian GluudCopenhagen Trial Unit, Centre for Clinical Intervention Research, Capital Region of Denmark, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Janus Christian JakobsenCopenhagen Trial Unit, Centre for Clinical Intervention Research, Capital Region of Denmark, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Copenhagen University Hospital · DKUniversity of Southern Denmark · DKNorth East London NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionNeurodevelopmental 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.

Indexed as

Drug-Related Side Effects and Adverse ReactionsMelatoninNeurodevelopmental DisordersSleep Wake DisordersChildHumansMeta-Analysis as TopicQuality of LifeRandomized Controlled Trials as TopicSleep LatencySystematic Reviews as TopicMelatoninDevelopmental neurology & neurodisabilityPaediatric neurologySLEEP MEDICINE

Identifiers

PMID36446459
PMCPMC9710329
OpenAlexW4310360060

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.