NCT04192942

Brief Summary

Decrease mortality and morbidity in major pediatric burns

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

December 10, 2019

Status Verified

December 1, 2019

Enrollment Period

1.5 years

First QC Date

October 14, 2019

Last Update Submit

December 9, 2019

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

  • Changing mortality rate

    Change mortality rate to lowest degree which due too severe burn less than 20% of childern with major burn

    baseline

Secondary Outcomes (1)

  • Changing hospital stay time

    Baseline

Study Arms (1)

intensive care management

EXPERIMENTAL

Administration of childern with major burn in intensive care to improve out comes

Other: protocol of management of major burn in intensive care unit

Interventions

protocol of management of major burn in intensive care unitOTHER

primary assessment first aid management laboratory investigation radiological investigation surgical intervention

intensive care management

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age below 18 year
  • children with burn between 20% to 50% of total body surface area
  • recent burn within 48 hour

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 23181206BACKGROUND

  • 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.

    PMID: 19919684BACKGROUND

MeSH Terms

Conditions

Burns

Interventions

Intensive Care Units

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hospital UnitsHealth FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Azza Eltayeb, Professor

    Professor

    STUDY DIRECTOR

Central Study Contacts

Mohamed elsayed, doctor

CONTACT

01029980167mohamed011349@med.au.edu.eg

Youssef saleh, professor

CONTACT

01001166118

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Official investigator

Study Record Dates

First Submitted

October 14, 2019

First Posted

December 10, 2019

Study Start

December 1, 2019

Primary Completion

June 1, 2021

Study Completion

September 1, 2021

Last Updated

December 10, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share