Melatonin for Cerebral Palsy Children's Sleep and Health

Ain Shams University

Status: Completed

Conditions: Cerebral Palsy; Children, Only; Growth; Melatonin

Treatments: Drug: Melatonin 3 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04392063

FMASU MD 202/2016

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Cerebral palsy

Other group

Description:

Not included

Treatment:

Drug: Melatonin 3 mg