BurnsPhase 3NCT01464866
Effect of Nutritional Supplementation on Pediatric Burn Patients
A Phase 3 study testing Nutritional Supplement and Hospital food in people with Burns, run by Abbott Nutrition at 9 sites in Russia.
Trial summary
This study will determine the effect of nutrition supplementation on blood protein levels in pediatric burn patients. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Burns
- What is being tested?
- Nutritional Supplement and Hospital food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 9 sitesRussia
- Study dates
- Feb 2010to Sep 2011
- Phase
- Phase 3
- 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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1-10 years of age
- Hospital admission within 24 hours post-burn
- At least 15% TBSA burned to at least 2nd degree and no more than 5% TBSA 4th degree or higher
- Capable of exclusive oral feeding within 3 days of hospitalization
- Expected to be hospitalized at least 14 days
Who cannot join
- History diabetes or stress-induced hyperglycemia
- Artificial ventilation
- Requires parenteral or enteral feeding
- IV albumin
- Drug that affects metabolism
- Receiving Dialysis
Show all 10Show fewer
- Acutely impacted or constipated
- Consumes non-study nutritional supplement
- Allergy or intolerance to any study product ingredient
- Participating in non-Abbott approved concomitant trial
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Russia9 sites
First Republic Clinical Hospital of Ministry of Healthcare of Udmurtia Republic
Izhevsk, 426039
Children's Republican Clinical Hospital of Ministry of Healthcare of Tatarstan Republic
Kazan', 420138
City Clinical Hospital #2
Kemerovo, 650033
Children's City Hospital #9
Moscow, 123317
Nizhny Novgorod Research Institute of Traumatology & Orthopedics of Federal Agency of High Technology Medical Care
Nizhny Novgorod, 603155
City Hospital #20
Rostov-on-Don, 344091
Children's City Hospital #1
Saint Petersburg, 198205
City Clinical Hospital #7
Saratov, 410005
Children City Clinical Hospital #9
Yekaterinburg, 620134
About this study
This study will determine the effect of nutrition supplementation on blood protein levels in pediatric burn patients.
- Conditions
- Burns
- Being tested
- Nutritional Supplement, Hospital food
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional SupplementOther
Liquid, pediatric nutritional supplement. 1-2 bottles/day for up to 28 days.
Hospital foodOther
Typical hospital food given daily at meals
| Study group | Role | What they receive |
|---|---|---|
| Hospital Feed | Active comparator | Standard hospital food Receives: Other: Hospital food |
| Hospital Feed plus nutritional supplement | Experimental | Standard hospital food plus nutritional supplement Receives: Other: Nutritional Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
prealbumin
Measured: Change between Baseline and Day 14
Secondary outcomes (3)
Preablumin
Measured: Change between Baseline and Day 7
C Reactive Protein (CRP)
Measured: Between baseline and Day 7
C Reactive Protein
Measured: Between baseline and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study startFeb 2010
- Primary completionJul 2011
- Study completionSep 2011
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Williams, MPH, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464866
- Sponsor's protocol ID
- BK56
- Status last verified
- Nov 2011
- First submitted
- 1 Nov 2011
- Last updated
- 6 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nutritional Supplementation on Pediatric Burn Patients
- ClinicalTrials.gov ID
- NCT01464866
- Acronym / sponsor ID
- BK56
- Conditions
- Burns
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 4 Nov 2011 (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.
This study will determine the effect of nutrition supplementation on blood protein levels in pediatric burn patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospital Feed | Active comparator | Other: Hospital foodStandard hospital food |
| Hospital Feed plus nutritional supplement | Experimental | Other: Nutritional SupplementStandard hospital food plus nutritional supplement |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 1-10 years of age
- Hospital admission within 24 hours post-burn
- At least 15% TBSA burned to at least 2nd degree and no more than 5% TBSA 4th degree or higher
- Capable of exclusive oral feeding within 3 days of hospitalization
- Expected to be hospitalized at least 14 days
Key exclusion criteria (10 listed)
- History diabetes or stress-induced hyperglycemia
- Artificial ventilation
- Requires parenteral or enteral feeding
- IV albumin
- Drug that affects metabolism
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 |
|---|---|---|
| Nutritional SupplementLiquid, pediatric nutritional supplement. 1-2 bottles/day for up to 28 days. | Other | Hospital Feed plus nutritional supplement |
| Hospital foodTypical hospital food given daily at meals | Other | Hospital Feed |
Primary outcome
prealbumin
Time frame: Change between Baseline and Day 14
3 secondary outcomes
Preablumin
Time frame: Change between Baseline and Day 7
C Reactive Protein (CRP)
Time frame: Between baseline and Day 7
C Reactive Protein
Time frame: Between baseline and Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 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.
Jennifer Williams, MPH study chair
Abbott Nutrition
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nutritional Supplement and Hospital food in people with Burns, run by Abbott Nutrition at 9 sites in Russia.
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 5 inclusion and 10 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: finished, as of the sponsor's last update on 6 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Russia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
prealbumin (time frame: Change between Baseline and Day 14). 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 6 Sep 2012.