- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04192942
Protocol of Management of Major Pediatric Burn in Intensive Care Unit
December 9, 2019 updated by: Mohamed elsayed tawfik, Assiut University
Decrease mortality and morbidity in major pediatric burns
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age below 18 year
- children with burn between 20% to 50% of total body surface area
- recent burn within 48 hour
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: intensive care management
Administration of childern with major burn in intensive care to improve out comes
|
primary assessment first aid management laboratory investigation radiological investigation surgical intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changing hospital stay time
Time Frame: Baseline
|
Hospital stay less than 30 days
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Azza Eltayeb, Professor, PROFESSOR
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Williams 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
December 1, 2019
Primary Completion (ANTICIPATED)
June 1, 2021
Study Completion (ANTICIPATED)
September 1, 2021
Study Registration Dates
First Submitted
October 14, 2019
First Submitted That Met QC Criteria
December 9, 2019
First Posted (ACTUAL)
December 10, 2019
Study Record Updates
Last Update Posted (ACTUAL)
December 10, 2019
Last Update Submitted That Met QC Criteria
December 9, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- major burn in childern
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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