Melatonin for Cerebral Palsy Children's Sleep and Health

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04392063
• Other study ID #: FMASU MD 202/2016
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: September 2018

Study information

• Verified date: May 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

Inclusion Criteria:

• All cerebral palsy children with sleep problem and seizure disorder,

• aged 2 - 12 years

Exclusion Criteria:

• any auditory and peripheral visual impairments

Related Conditions & MeSH terms

• Cerebral Palsy
• Children, Only
• Growth
• Melatonin

Intervention

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

Locations

Country	Name	City	State
Egypt	Children's Hospital, Faculty of Medicine, Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Elkhayat HA, Hassanein SM, Tomoum HY, Abd-Elhamid IA, Asaad T, Elwakkad AS. Melatonin and sleep-related problems in children with intractable epilepsy. Pediatr Neurol. 2010 Apr;42(4):249-54. doi: 10.1016/j.pediatrneurol.2009.11.002. — View Citation

Outcome

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

External Links

•   Published part of the work "Effect of Melatonin Supplementation on Gastrointestinal Problems and Growth of Children with Cerebral Palsy"