Melatonin for Cerebral Palsy Children's Sleep and Health

Not Applicable

Completed

• Conditions: Cerebral Palsy; Melatonin; Growth; Children, Only
• Interventions: Drug: Melatonin 3 mg

• Registration Number: NCT04392063
• Lead Sponsor: Ain Shams University

Brief Summary

The present study was prospective uncontrolled, single-armed and un-blinded study. Held in the Pediatric neurology clinic, Children's hospital l, Faculty of Medicine, Ain Shams University from June 2016 to June 2018 of 24 months timeframe. All cerebral palsy (CP) patients following up in Pediatric neurology clinic aged between 2 and 12 years. Melatonin given for 3 months. Anthropmetric measures, gastroeintestinal symptoms, Children's sleep habits questionnaire (CSHQ) Arabic version, polysomnography, Chalfont epilepsy severity score, and EEG were done at enrollment and after the 3-months.

Detailed Description

A prospective, cohort study conducted in Pediatric Neurology Clinic, Children's Hospital, Faculty of Medicine, Ain Shams University. Forty children with sCP with sleep and seizure problems, aged 2-12 years were enrolled. The children received crushed Melatonin 3-mg tablets daily, 30-minutes before bedtime for 3-months. Children's sleep habits questionnaire (CSHQ) Arabic version, polysomnography, Chalfont epilepsy severity score, and EEG were done at enrollment and after the 3-months. The ethical approval number is (FMASU MD 202/2016).

Study Timeline

• Study Start: 2016-06
• Primary Completion: 2018-06
• Study Completion: 2018-09
• Status Verified: 2020-05
• Study First Submitted: 2020-05-10
• Study First Submitted QC: 2020-05-13
• Last Update Submitted: 2020-05-13
• Study First Posted: 2020-05-18
• Last Update Posted: 2020-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• All cerebral palsy children with sleep problem and seizure disorder,
• aged 2 - 12 years

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Exclusion Criteria

• any auditory and peripheral visual impairments

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cerebral palsy	Melatonin 3 mg	Not included

Primary Outcome Measures

Name	Time	Method
Improvement in growth	3-months	response to melatonin in improvement of growth
Decrease in total Children's sleep habits questionnaire score	after 3-months	response to melatonin as decrease in total sleep score

Trial Locations

Locations (1)

Children's Hospital, Faculty of Medicine, Ain Shams University; 🇪🇬 Cairo, Egypt