| NCT ID | NCT05869825 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Emory University |
| Condition | Congenital Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-02-27 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-02-27 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 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.
Contact & Investigator
Asaad Beshish, MD
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT05869825 clinical trial?
This trial is open to participants of all sexes, up to 1 Year, studying Congenital Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05869825 currently recruiting?
Yes, NCT05869825 is actively recruiting participants. Contact the research team at beshisha@kidsheart.com for enrollment information.
Where is the NCT05869825 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT05869825 clinical trial?
NCT05869825 is sponsored by Emory University. The principal investigator is Asaad Beshish, MD at Emory University. The trial plans to enroll 200 participants.