Melatonin for Cerebral Palsy Children's Sleep and Health
Effect of Melatonin Supplementation on Sleep and Health of Children With Cerebral Palsy
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedFirst Submitted
Initial submission to the registry
May 10, 2020
CompletedFirst Posted
Study publicly available on registry
May 18, 2020
CompletedMay 18, 2020
May 1, 2020
2 years
May 10, 2020
May 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Decrease in total Children's sleep habits questionnaire score
response to melatonin as decrease in total sleep score
after 3-months
Improvement in growth
response to melatonin in improvement of growth
3-months
Study Arms (1)
Cerebral palsy
OTHERNot included
Interventions
The children received crushed Melatonin 3-mg tablets daily, 30-minutes before bedtime for 3-months.
Eligibility Criteria
You may qualify if:
- All cerebral palsy children with sleep problem and seizure disorder,
- aged 2 - 12 years
You may not qualify if:
- any auditory and peripheral visual impairments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital, Faculty of Medicine, Ain Shams University
Cairo, 11381, Egypt
Related 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.
PMID: 20304327RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
May 10, 2020
First Posted
May 18, 2020
Study Start
June 1, 2016
Primary Completion
June 1, 2018
Study Completion
September 1, 2018
Last Updated
May 18, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share