Back to resultsProtocol of Management of Major Pediatric Burn in Intensive Care Unit
Primary Purpose
Burns
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
protocol of management of major burn in intensive care unit
Sponsored by
About this trial
This is an interventional treatment trial for Burns
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intensive care management
Arm Description
Administration of childern with major burn in intensive care to improve out comes
Outcomes
Primary Outcome Measures
Changing mortality rate
Change mortality rate to lowest degree which due too severe burn less than 20% of childern with major burn
Secondary Outcome Measures
Changing hospital stay time
Hospital stay less than 30 days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04192942
Brief Title
Protocol of Management of Major Pediatric Burn in Intensive Care Unit
Official Title
Protocol of Management of Major Pediatric Burn in Intensive Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2019 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intensive care management
Arm Type
Experimental
Arm Description
Administration of childern with major burn in intensive care to improve out comes
Intervention Type
Other
Intervention Name(s)
protocol of management of major burn in intensive care unit
Intervention Description
primary assessment first aid management laboratory investigation radiological investigation surgical intervention
Primary Outcome Measure Information:
Title
Changing mortality rate
Description
Change mortality rate to lowest degree which due too severe burn less than 20% of childern with major burn
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Changing hospital stay time
Description
Hospital stay less than 30 days
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed elsayed, doctor
Phone
01029980167
Email
mohamed011349@med.au.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Youssef saleh, professor
Phone
01001166118
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Azza Eltayeb, Professor
Organizational Affiliation
Professor
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23181206
Citation
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.
Results Reference
background
PubMed Identifier
19919684
Citation
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.
Results Reference
background
Learn more about this trial
Protocol of Management of Major Pediatric Burn in Intensive Care Unit
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