Comparing two methods of breathing support after heart surgery in infants
Official title: High Flow Nasal Cannula and Non-Invasive Positive Pressure Ventilation Following Extubation in Infants After Cardiac Surgery for Congenital Heart Disease: A Randomized Clinical Trial
Run by Emory University · NCT05869825 · Data updated 2026-11-12
This study is testing which breathing support method, High Flow Nasal Cannula or Non-Invasive Positive Pressure Ventilation, works better for infants with heart defects after heart surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 1 Year |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Status | Recruiting |
| Started | February 27, 2025 |
| Main results expected | March 2027 |
| Study ends | March 2027 |
| Registry record updated | July 14, 2026 |
| Trial ID | NCT05869825 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants aged 0 to 1 year who are admitted to the Cardiac Intensive Care Unit following cardiac surgery for Congenital Heart Disease.
✕Probably not a fit
Patients who remain intubated for 4 weeks or longer, have a tracheostomy, or have significant extracardiac anomalies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to determine the most effective method of respiratory support following extubation in infants with Congenital Heart Disease (CHD) after cardiac surgery. It will compare High Flow Nasal Cannula (HFNC) and Non-Invasive Positive Pressure Ventilation (NIPPV) to assess their impact on extubation failure rates and overall health outcomes. The study will involve 200 infants aged 0 to 1 year in the Cardiac Intensive Care Unit at Children's Healthcare of Atlanta, monitoring their recovery and respiratory support needs. By identifying the best approach, the study seeks to improve care for this vulnerable population.
Why it matters
Potential benefit: If successful, this study could lead to improved respiratory support strategies, reducing extubation failure rates and enhancing recovery for infants after cardiac surgery.
How similar studies have gone: While there is limited data specifically comparing HFNC and NIPPV in this population, studies have shown varying success with different respiratory support methods in similar contexts.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Arthur M. Blank Hospital | Children's Healthcare of Atlanta
Atlanta, Georgia, United States Recruiting
Study contacts
- Principal investigator: Asaad Beshish, MD — Emory University
- Study coordinator: Asaad Beshish, MD
- Email: beshisha@kidsheart.com
- Phone: 404.785.6953
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.