Cardiac Arrhythmias and Dysfunction in the Pediatric Burn Patient

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect information about how often an abnormal heart beat happens in children who have been burned.

Detailed Description
-----------------
The investigators hope to learn the following: If heart arrhythmias are more common in children with a large burn injury than in children with a small burn injury. The difference in development of a heart arrhythmia after a large burn injury by comparing information from children with large burns who do and do not develop a heart arrhythmia. A better understanding of the length of a hospital stay, the number of operations, and the number of care complications in patients with heart arrhythmias after a burn injury.

Official Title
-----------------
Cardiac Arrhythmias and Dysfunction in the Pediatric Burn Patient

Conditions
-----------------
Cardiac Dysfunction

Intervention / Treatment
-----------------
* Diagnostic Test: Echocardiogram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric burn patients from age 0 - 18 who have sustained a burn injury will be eligible for this study. Group 1 will consist of patients with ≥30% TBSA burn injury. Group 2 will consist of patients with <30% TBSA burn injury who develop a cardiac abnormality. Exclusion Criteria: Patients with pre-existing cardiac disorder, desquamative skin disorders and electrical injury.

Ages Eligible for Study
-----------------
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ≥30% TBSA burn injury<br>For patients in Group 1 with ≥30% TBSA, a baseline Echocardiogram (ECHO) will be obtained approximately one week from admission and monthly (+/- 1 week) or at an interval determined by cardiology during the acute inpatient stay. ECHO tests will be discontinued after 3 negative exams or when discontinued by cardiology, whichever comes first. | Diagnostic Test: Echocardiogram<br>* A baseline Echocardiogram test (ECHO) will be done one week from admission and monthly (+/- 1 week) or as ordered by a cardiologist.<br>* Other names: ECHO;|
| No Intervention: <30% TBSA burn injury<br>For patients in Group 2 with <30% TBSA and presence of a cardiac abnormality standard clinical care appropriate for the type of arrhythmia will be followed. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of cardiac dysfunction in pediatric burn patients | Results of echocardiograms will be compared between patients with cardiac dysfunction versus those without cardiac dysfunction. | Through study completion up to 4 years after hospital discharge. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute care hospital length of stay | Hospital length of stay (admission date to discharge date) will be compared between participants with cardiac dysfunction versus participants without cardiac dysfunction. | Hospital admission to discharge (average of 1 day per %TBSA burn - example 30 days for a 30% TBSA burn injury). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Burns, Pediatrics, Cardiac Arrhythmia