No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
Up to 1
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
Emory University · Other
Who this trial is looking for
This trial is looking for infants under 1 year old who have congenital heart disease and are recovering from heart surgery. Participants will receive one of two common types of breathing support to see which one works better after extubation.
Are You a Good Fit for This Trial?
You may be able to join if
I am an infant under 1 year old.
I have congenital heart disease.
I have had heart surgery.
I weigh 10 kg or less.
You may not be able to join if
I have been intubated for 4 weeks or more.
I had a tracheostomy before my heart surgery.
I am in another research study.
I need ECMO support before my surgery.
I weighed less than 2 kg at birth.
I was born before 35 weeks of pregnancy.
I have serious health issues outside of my heart condition.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study has the goal to determine the best method of respiratory support following extubation after cardiac surgery (CS). After cardiac surgery for Congenital Heart Disease (CHD), patients remain intubated until the cardiac team determines it is safe for the patient to undergo a trial of extubation. Two common methods of respiratory support following extubation are High Flow Nasal Cannula (HFNC…
This study has the goal to determine the best method of respiratory support following extubation after cardiac surgery (CS). After cardiac surgery for Congenital Heart Disease (CHD), patients remain intubated until the cardiac team determines it is safe for the patient to undergo a trial of extubation. Two common methods of respiratory support following extubation are High Flow Nasal Cannula (HFNC) and Non Invasive Positive Pressure Ventilation (NIPPV). There is currently a gap in data comparing High Flow Nasal Cannula and Non-Invasive Positive Pressure Ventilation in infants (age 0-1) in regard to extubation failure and overall outcomes.
This study will monitor the health outcomes of 200 infants (0 - 1 year) with CHD following cardiac surgery in the Cardiac Intensive Care Unit (CICU) at Children's Healthcare of Atlanta (CHOA). This will be done by assigning the respiratory support method each child will receive following extubation after cardiac surgery. Health outcomes will be monitored until discharge or until the second instance of extubation failure.
Both study arms are standard-of-care respiratory support methods in the CHOA CICU. The investigators aim to determine which of these two methods has fewer risk factors when used with infants.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* All patients admitted to the CICU following cardiac surgery for CHD who are \</= 1 year of age and/or weight \</= 10 kg
Exclusion Criteria:
* Patients who remain intubated for \>/= 4 weeks
* Patients who have a tracheostomy prior to their cardiac surgery
* Patient enrolled i…
Inclusion Criteria:
* All patients admitted to the CICU following cardiac surgery for CHD who are \</= 1 year of age and/or weight \</= 10 kg
Exclusion Criteria:
* Patients who remain intubated for \>/= 4 weeks
* Patients who have a tracheostomy prior to their cardiac surgery
* Patient enrolled in a competing research study
* Patients requiring extracorporeal membrane oxygenation (ECMO) support preoperatively
* Patients with birth weight \< 2 Kg.
* Gestational age \< 35 weeks at birth.
* Patients with extracardiac anomalies more than minor severity.
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