Back to resultsMelatonin for Cerebral Palsy Children's Sleep and Health
Primary Purpose
Cerebral Palsy, Melatonin, Growth
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Melatonin 3 mg
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Children's sleep habits questionnaire (CSHQ) Arabic version, Anthropometry, GERD, Constipation, Polysomnography
Eligibility Criteria
Inclusion Criteria:
- All cerebral palsy children with sleep problem and seizure disorder,
- aged 2 - 12 years
Exclusion Criteria:
- any auditory and peripheral visual impairments
Sites / Locations
- Children's Hospital, Faculty of Medicine, Ain Shams University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cerebral palsy
Arm Description
Not included
Outcomes
Primary Outcome Measures
Decrease in total Children's sleep habits questionnaire score
response to melatonin as decrease in total sleep score
Improvement in growth
response to melatonin in improvement of growth
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04392063
Brief Title
Melatonin for Cerebral Palsy Children's Sleep and Health
Official Title
Effect of Melatonin Supplementation on Sleep and Health of Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
September 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Melatonin, Growth, Children, Only
Keywords
Children's sleep habits questionnaire (CSHQ) Arabic version, Anthropometry, GERD, Constipation, Polysomnography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A prospective, cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cerebral palsy
Arm Type
Other
Arm Description
Not included
Intervention Type
Drug
Intervention Name(s)
Melatonin 3 mg
Other Intervention Name(s)
Melatonin CP
Intervention Description
The children received crushed Melatonin 3-mg tablets daily, 30-minutes before bedtime for 3-months.
Primary Outcome Measure Information:
Title
Decrease in total Children's sleep habits questionnaire score
Description
response to melatonin as decrease in total sleep score
Time Frame
after 3-months
Title
Improvement in growth
Description
response to melatonin in improvement of growth
Time Frame
3-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All cerebral palsy children with sleep problem and seizure disorder,
aged 2 - 12 years
Exclusion Criteria:
any auditory and peripheral visual impairments
Facility Information:
Facility Name
Children's Hospital, Faculty of Medicine, Ain Shams University
City
Cairo
ZIP/Postal Code
11381
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20304327
Citation
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.
Results Reference
result
Links:
URL
https://platform.almanhal.com/Reader/Article/130441
Description
Published part of the work "Effect of Melatonin Supplementation on Gastrointestinal Problems and Growth of Children with Cerebral Palsy"
Learn more about this trial
Melatonin for Cerebral Palsy Children's Sleep and Health
We'll reach out to this number within 24 hrs