BurnsNCT00539019
Quantification and Derivation of Metabolic Needs in Children During Burn Rehabilitation
An observational study of Burns, run by Shriners Hospitals for Children at 1 site in United States.
Trial summary
The investigators are collecting information on the calorie needs of patients in the first year postburn. The investigators hypothesize that increased energy needs continue for up to a year following wound closure from burn injury. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Burns
- What is being tested?
- calories measured 5x following wound healing
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to not given
- Phase
- Observational
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: burned, pediatrics pooled from inpatient acute population
Who may be able to join
- >25% burn surface area
- Wounds present as 95% healed
- Admitted to Shriners Hospital Cincinnati within 7 days of injury
Who cannot join
- <5years old
- <25% burn injury
- admitted greater than 7 days postburn
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospital for Children
Cincinnati, Ohio, 45229
About this study
The investigators are collecting information on the calorie needs of patients in the first year postburn. The investigators hypothesize that increased energy needs continue for up to a year following wound closure from burn injury.
- Conditions
- Burns
- Being tested
- calories measured 5x following wound healing
- Keywords
- nutrition assessment, pediatric
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calories measured 5x following wound healingOther
measure REE at various time points postburn
| Study group | Role | What they receive |
|---|---|---|
| A, observed | measure REE via indirect calorimetry at various time points post burn Receives: Other: calories measured 5x following wound healing |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2007 (estimated)
- Study startOct 2006
Why it stopped: indirect calorimetry no longer employed at the institution; calorimeter is not accurate/reliable
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
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theresa Mayes, Shriners Hospitals for Children
- Investigators
- Theresa M Mayes, RD,LD, Principal investigator, Shriners Hospital for Children, Cincinnati, Ohio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539019
- Sponsor's protocol ID
- 05-11-17-03-EE
- Status last verified
- Jun 2012
- First submitted
- 1 Oct 2007
- Last updated
- 19 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification and Derivation of Metabolic Needs in Children During Burn Rehabilitation
- ClinicalTrials.gov ID
- NCT00539019
- Acronym / sponsor ID
- 05-11-17-03-EE
- Conditions
- Burns
- Keywords
- nutrition assessment, pediatric
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: indirect calorimetry no longer employed at the institution; calorimeter is not accurate/reliable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Study start
- Oct 2006
- First posted
- 3 Oct 2007 (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 investigators are collecting information on the calorie needs of patients in the first year postburn. The investigators hypothesize that increased energy needs continue for up to a year following wound closure from burn injury.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A, observed | – | Other: calories measured 5x following wound healingmeasure REE via indirect calorimetry at various time points post burn |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- burned, pediatrics pooled from inpatient acute population
Key inclusion criteria (3 listed)
- >25% burn surface area
- Wounds present as 95% healed
- Admitted to Shriners Hospital Cincinnati within 7 days of injury
Key exclusion criteria (3 listed)
- <5years old
- <25% burn injury
- admitted greater than 7 days postburn
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 |
|---|---|---|
| calories measured 5x following wound healingmeasure REE at various time points postburn | Other | A, observed |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2012.
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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.
Theresa M Mayes, RD,LD principal investigator
Shriners Hospital for Children, Cincinnati, Ohio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 3 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: withdrawn, as of the sponsor's last update on 19 Jun 2012. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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.
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 19 Jun 2012.