BurnsPhase 2Sleep6NCT01598259
Randomized Controlled Trial to Assess Efficacy of Melatonin for Children During Burn Rehabilitation
A Phase 2 study testing Melatonin in people with Burns, run by Shriners Hospitals for Children at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 5 to 22 years
- Conditions the study is for
- Burns
- What is being tested?
- Melatonin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jun 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- History of burn injury
- Scheduled for an elective surgical procedure
- 5 - 22 years of age, inclusive
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospital for Children
Cincinnati, Ohio, 45229
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
po 1 hour before bedtime
placeboOther
po, 1 hour before bed
| Study group | Role | What they receive |
|---|---|---|
| melatonin | Experimental | Subjects will receive melatonin Receives: Drug: Melatonin |
| placebo | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep
Measure sleep parameters via polysomnography, actigraphy and urinary melatonin
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startMay 2014
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: lack or enrollment, funding depletion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Gottschlich, Shriners Hospitals for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598259
- Sponsor's protocol ID
- 2012-1613
- Acronym
- Sleep6
- Status last verified
- Jun 2016
- First submitted
- 8 May 2012
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: given low level of enrollment and hence, randomization (n=3), no plans to provide data
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Assess Efficacy of Melatonin for Children During Burn Rehabilitation
- ClinicalTrials.gov ID
- NCT01598259
- Acronym / sponsor ID
- Sleep6 / 2012-1613
- Conditions
- Burns
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack or enrollment, funding depletion
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 15 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| melatonin | Experimental | Drug: MelatoninSubjects will receive melatonin |
| placebo | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 5 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- History of burn injury
- Scheduled for an elective surgical procedure
- 5 - 22 years of age, inclusive
Key exclusion criteria (13 listed)
- History of anoxic brain injury
- History of head injury within the last year
- Pre-existing seizure disorder
- Pre-existing neurological disorder
- Pre-existing blindness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatoninpo 1 hour before bedtime | Drug | melatonin |
| placebopo, 1 hour before bed | Other | placebo |
Primary outcome
sleep
Time frame: 3 years
Measure sleep parameters via polysomnography, actigraphy and urinary melatonin
Results and safety
The study was stopped early (reason given: lack or enrollment, funding depletion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
- Individual participant dataSharing planned: No. given low level of enrollment and hence, randomization (n=3), no plans to provide data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melatonin in people with Burns, run by Shriners Hospitals for Children at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack or enrollment, funding depletion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2016; AzTrials last refreshed its copy on 7 Nov 2026.