BurnsNCT04192942
Protocol of Management of Major Pediatric Burn in Intensive Care Unit
A study testing protocol of management of major burn in intensive care unit in people with Burns, run by Assiut University.
Trial summary
Decrease mortality and morbidity in major pediatric burns Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Burns
- What is being tested?
- protocol of management of major burn in intensive care unit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2019to Sep 2021
- Phase
- Interventional
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age below 18 year
- children with burn between 20% to 50% of total body surface area
- recent burn within 48 hour
Who cannot join
- old burn over 48 hour after injury -burnt surface area less than 20% of total body surface area - -
- burnt surface area more than 50% of total body surface area
- old age over 18 year
Trial locations and contacts
No sites are listed yet.
Youssef saleh, professor contact
About this study
Decrease mortality and morbidity in major pediatric burns
Read the detailed description
The goals of initial patient management include preservation of overall homeostasis while appreciating the physiologic challenges that the burn injury poses to the body. Major burn injury not only results in local damage from the inciting injury, but in many cases results in multisystem injury. Initial efforts are focused on resuscitation, maintaining hemodynamic stability, and airway management. Intermediate efforts are focused on managing the multi-organ failure that results from systemic inflammatory mediators that result in diffuse capillary leak and surgical therapy. Finally, efforts shift to issues with chronic wound healing, pain management, restoration of functional capabilities, and rehabilitation.. Burn injury in children continues to be a major epidemiologic problem around the globe. Nearly a fourth of all burn injuries occur in children under the age of 16, of whom the majority are under the age of five This provides a team of pediatricians, surgeons, anesthesiologists, intensivists, nurses, respiratory therapists, and other healthcare providers with a unique opportunity to make a multidisciplinary collaborative effort.
- Conditions
- Burns
- Being tested
- protocol of management of major burn in intensive care unit
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protocol of management of major burn in intensive care unitOther
primary assessment first aid management laboratory investigation radiological investigation surgical intervention
| Study group | Role | What they receive |
|---|---|---|
| intensive care management | Experimental | Administration of childern with major burn in intensive care to improve out comes Receives: Other: protocol of management of major burn in intensive care unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing mortality rate
Change mortality rate to lowest degree which due too severe burn less than 20% of childern with major burn
Measured: baseline
Secondary outcomes (1)
Changing hospital stay time
Hospital stay less than 30 days
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study startDec 2019 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed elsayed tawfik, Assiut University
- Investigators
- Azza Eltayeb, Professor, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192942
- Sponsor's protocol ID
- major burn in childern
- Status last verified
- Dec 2019
- First submitted
- 14 Oct 2019
- Last updated
- 10 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krishnamoorthy V, Ramaiah R, Bhananker SM. Pediatric burn injuries. Int J Crit Illn Inj Sci. 2012 Sep;2(3):128-34. doi: 10.4103/2229-5151.100889.
PubMed 23181206Williams FN, Herndon DN, Hawkins HK, Lee JO, Cox RA, Kulp GA, Finnerty CC, Chinkes DL, Jeschke MG. The leading causes of death after burn injury in a single pediatric burn center. Crit Care. 2009;13(6):R183. doi: 10.1186/cc8170. Epub 2009 Nov 17.
PubMed 19919684
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol of Management of Major Pediatric Burn in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04192942
- Acronym / sponsor ID
- major burn in childern
- Conditions
- Burns
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 10 Dec 2019 (actual)
- 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.
Decrease mortality and morbidity in major pediatric burns
Detailed description
The goals of initial patient management include preservation of overall homeostasis while appreciating the physiologic challenges that the burn injury poses to the body. Major burn injury not only results in local damage from the inciting injury, but in many cases results in multisystem injury. Initial efforts are focused on resuscitation, maintaining hemodynamic stability, and airway management. Intermediate efforts are focused on managing the multi-organ failure that results from systemic inflammatory mediators that result in diffuse capillary leak and surgical therapy. Finally, efforts shift to issues with chronic wound healing, pain management, restoration of functional capabilities, and rehabilitation.. Burn injury in children continues to be a major epidemiologic problem around the globe. Nearly a fourth of all burn injuries occur in children under the age of 16, of whom the majority are under the age of five This provides a team of pediatricians, surgeons, anesthesiologists, intensivists, nurses, respiratory therapists, and other healthcare providers with a unique opportunity to make a multidisciplinary collaborative effort.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intensive care management | Experimental | Other: protocol of management of major burn in intensive care unitAdministration of childern with major burn in intensive care to improve out comes |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- age below 18 year
- children with burn between 20% to 50% of total body surface area
- recent burn within 48 hour
Key exclusion criteria (3 listed)
- old burn over 48 hour after injury -burnt surface area less than 20% of total body surface area - -
- burnt surface area more than 50% of total body surface area
- old age over 18 year
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 |
|---|---|---|
| protocol of management of major burn in intensive care unitprimary assessment first aid management laboratory investigation radiological investigation surgical intervention | Other | intensive care management |
Primary outcome
Changing mortality rate
Time frame: baseline
Change mortality rate to lowest degree which due too severe burn less than 20% of childern with major burn
1 secondary outcome
Changing hospital stay time
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
- Background: PubMed 23181206Krishnamoorthy V, Ramaiah R, Bhananker SM. Pediatric burn injuries. Int J Crit Illn Inj Sci. 2012 Sep;2(3):128-34. doi: 10.4103/2229-5151.100889.
- Background: PubMed 19919684Williams FN, Herndon DN, Hawkins HK, Lee JO, Cox RA, Kulp GA, Finnerty CC, Chinkes DL, Jeschke MG. The leading causes of death after burn injury in a single pediatric burn center. Crit Care. 2009;13(6):R183. doi: 10.1186/cc8170. Epub 2009 Nov 17.
- Individual participant dataSharing planned: No
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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.
Youssef saleh, professor contact
Azza Eltayeb, Professor study director
Professor
Questions about this trial
What is this clinical trial studying?
A study testing protocol of management of major burn in intensive care unit in people with Burns, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed elsayed, doctor (01029980167, mohamed011349@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changing mortality rate (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04192942, which also lists 2 linked publications.
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 10 Dec 2019.