NCT04392063

Melatonin for Cerebral Palsy Children's Sleep and Health

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cerebral Palsy
• Melatonin
• Growth
• Children, Only

Interventions

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

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-06-01
• Completion: 2018-09-01
• First posted: 2020-05-18
• Last updated: 2020-05-18

Locations

1 site across 1 country: Egypt