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Differential Effects of Eszopiclone Versus Ramelteon in Burned Children

This study is not yet open for participant recruitment.
Verified by Shriners Hospitals for Children, October 2007

Sponsored by: Shriners Hospitals for Children
Information provided by: Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT00539110
  Purpose

To examine sleep changes following therapeutic drug interventions designed to promote sleep.


Condition Intervention
Sleep
Burns
Drug: eszopiclone
Drug: ramelteon

MedlinePlus related topics:   Burns   

Drug Information available for:   Ramelteon    Eszopiclone   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment

Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • polysomnography data [ Time Frame: 2 weeks postburn ]

Secondary Outcome Measures:
  • hormone levels [ Time Frame: 2 weeks postburn ]

Estimated Enrollment:   50

  Eligibility
Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Burn injury > 20% total body surface area
  • Between 3 and 18 years of age
  • < 7 days from acute injury
  • Written informed consent and HIPPA release signed

Exclusion Criteria:

  • Suspected anoxic brain injury or head injury
  • Hepatic or endocrine disease
  • History of alcoholism or substance abuse
  • Pre-existing neurological or primary psychiatric disorder
  • Medical history of pre-existing sleep disorder or lactose deficiency
  • Questionable survival (<72 hrs) as decided by PI
  • Receipt of drugs with known effects on sleep within 24 hrs of study entry
  • No informed consent/HIPPA release
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539110

Contacts
Contact: Michele M Gottschlich, PhD, RD, CNSD     513-872-6298     mgottschlich@shrinenet.org    
Contact: Theresa Mayes, BS, RD     513-872-6043     tmayes@shrinenet.org    

Locations
United States, Ohio
Shriners Hospital for Children    
      Cincinnati, Ohio, United States, 45229

Sponsors and Collaborators
Shriners Hospitals for Children

Investigators
Principal Investigator:     Michele M Gottschlich     Shriners Hospital for Children    
  More Information


Study ID Numbers:   Sleep III
First Received:   October 2, 2007
Last Updated:   October 3, 2007
ClinicalTrials.gov Identifier:   NCT00539110
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Burns

ClinicalTrials.gov processed this record on November 20, 2008




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