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

Burns Clinical Trial

— Sleep6  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01598259
• Other study ID #: 2012-1613
• Status: Terminated
• Phase: Phase 2
• First received: May 8, 2012
• Last updated: June 27, 2016
• Start date: May 2014
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Shriners Hospitals for Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 22 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns

Intervention

Drug:
• Melatonin
po 1 hour before bedtime

Other:
• placebo
po, 1 hour before bed

Locations

Country	Name	City	State
United States	Shriners Hospital for Children	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sleep	Measure sleep parameters via polysomnography, actigraphy and urinary melatonin	3 years	Yes