Melatonin for Cerebral Palsy Children's Sleep and Health

Effect of Melatonin Supplementation on Sleep and Health of Children With Cerebral Palsy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04392063

Enrollment

Registered

2020-05-18

Start date

2016-06-30

Completion date

2018-09-30

Last updated

2020-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Melatonin, Growth, Children, Only

Keywords

Children's sleep habits questionnaire (CSHQ) Arabic version, Anthropometry, GERD, Constipation, Polysomnography

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).

Interventions

DRUGMelatonin 3 mg

The children received crushed Melatonin 3-mg tablets daily, 30-minutes before bedtime for 3-months.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

A prospective, cohort study

Eligibility

Sex/Gender

ALL

Age

2 Years to 12 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* any auditory and peripheral visual impairments

Design outcomes

Primary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026