Melatonin for Cerebral Palsy Children's Sleep and Health | NCT04392063

Studies
Melatonin for Cerebral Palsy Children's Sleep and Health

NCT04392063

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

May 18, 2020Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Cerebral Palsy
Melatonin
Growth
Children, Only

Interventions

Melatonin 3 mg

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016Actual

Primary Completion Date

Jun 2018Actual

Completion Date

Sep 2018Actual

First Submitted Date

May 10, 2020

First Submission Date that Met QC Criteria

May 13, 2020

First Posted Date

May 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2020

Last Update Posted Date

May 18, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cerebral palsy	Other	Not included	Drug: Melatonin 3 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Melatonin 3 mg	Drug	The children received crushed Melatonin 3-mg tablets daily, 30-minutes before bedtime for 3-months.	Cerebral palsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital, Faculty of Medicine, Ain Shams University		Cairo		11381	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20304327	Result	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.

ID	Term
D002547	Cerebral Palsy
D005764	Gastroesophageal Reflux
D003248	Constipation

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D014363	Tryptamines
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring