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

NCT01598259 | Terminated Phase 2 DMC

• 1 other identifier: 2012-1613
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

• sleep

  Measure sleep parameters via polysomnography, actigraphy and urinary melatonin

  3 years

Study Arms (2)

melatonin

EXPERIMENTAL

Subjects will receive melatonin

Drug: Melatonin

placebo

PLACEBO COMPARATOR

Other: placebo

Interventions

Melatonin DRUG

po 1 hour before bedtime

melatonin

placebo OTHER

po, 1 hour before bed

placebo

Eligibility Criteria

• Age: 5 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• History of burn injury
• Scheduled for an elective surgical procedure
• years of age, inclusive

You may not qualify if:

• 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

Sponsors & Collaborators

• Shriners Hospitals for Children: lead

Study Sites (1)

Shriners Hospital for Children

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Burns

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: May 15, 2012
• Study Start: May 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 28, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)