Randomized Controlled Trial to Assess Efficacy of Melaton... | NCT01598259

Studies
Randomized Controlled Trial to Assess Efficacy of Melatonin for Children During Burn Rehabilitation

NCT01598259

Sponsor

Shriners Hospitals for Children

Status

Terminated

Last Update Posted

Jun 28, 2016Estimated

Enrollment

10Actual

Phase

Phase 2

Conditions

Burns

Interventions

Melatonin
placebo

Countries

United States

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

Jun 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack or enrollment, funding depletion

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

May 8, 2012

First Submission Date that Met QC Criteria

May 14, 2012

First Posted Date

May 15, 2012Estimated

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

Jun 27, 2016

Last Update Posted Date

Jun 28, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michele Gottschlich, Research Scientist, Shriners Hospitals for ChildrenPrincipal Investigator

Lead Sponsor

Shriners Hospitals for ChildrenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 specific aims of this investigation in children during burn rehabilitation include 1.) to determine the efficacy of melatonin intervention on improving sleep-related outcomes 2.) investigate the hypothesis that sleep inadequacy is associated with cognitive deficits and 3.) develop a new methodology specific for burn patients that accurately screens for the presence of intrinsic dyssomnia.

Detailed Description

Not provided

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
melatonin	Experimental	Subjects will receive melatonin	Drug: Melatonin
placebo	Placebo Comparator		Other: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Melatonin	Drug	po 1 hour before bedtime	melatonin
placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sleep	Measure sleep parameters via polysomnography, actigraphy and urinary melatonin	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

History of burn injury
Scheduled for an elective surgical procedure
5 - 22 years of age, inclusive

Exclusion Criteria:

History of anoxic brain injury
History of head injury within the last year
Pre-existing seizure disorder
Pre-existing neurological disorder
Pre-existing blindness
Known hypersensitivity to melatonin
Anticoagulant use or aspirin therapy
Antihypertensive medication use
Diabetes mellitus or other endocrine disorders
Autoimmune disorders
Schizophrenia
Inability to access internet
Intellectual disability or inability to follow directions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

22 Years

Standard Ages

ChildAdult

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
Shriners Hospital for Children		Cincinnati	Ohio	45229	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

given low level of enrollment and hence, randomization (n=3), no plans to provide data

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D002056	Burns

ID	Term
D014947	Wounds and Injuries

Intervention Browse Module

MeSH Terms

ID	Term
D008550	Melatonin

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided