HFNC vs NIPPV Following Extubation in Infants with Congenital Heart Disease

This study is comparing two ways to help infants breathe after heart surgery for congenital heart disease (CHD). After surgery, babies are often on a breathing machine (intubated) and then taken off (extubated). This study wants to find out if High Flow Nasal Cannula (HFNC) or Non-Invasive Positive Pressure Ventilation (NIPPV) is better at preventing breathing problems after extubation. Researchers will look at how well each method works to avoid needing the breathing tube again within two weeks after surgery. You might be able to join if you are an infant up to 1 year old or weighing up to 10 kg, admitted to the cardiac intensive care unit after heart surgery for CHD.

Study design
This study will involve 200 participants who will be randomly assigned to receive either High Flow Nasal Cannula or Non-Invasive Positive Pressure Ventilation.
What's involved
Participants will receive either High Flow Nasal Cannula or Non-Invasive Positive Pressure Ventilation following extubation, with clinical monitoring and respiratory support adjusted as needed.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome of avoiding extubation failures will be measured up to 2 weeks after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05869825

HFNC vs NIPPV Following Extubation

Recruiting
NAUp to 1InterventionalTreatment
Emory University
~200 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:High Flow Nasal Canula following extubationNon-Invasive Positive Pressure Ventilation following extubation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To compare the effectiveness in avoiding extubation failures of High Flow Nasal Cannula (HFNC) vs Non-Invasive Positive Pressure Ventilation (NIPPV)
Measured over After surgery up to 2 weeks
Congenital Heart Disease

NCT05869825

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Arthur M. Blank Hospital | Children's Healthcare of Atlanta

    Atlanta, Georgiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Asaad Beshish, MD · PRINCIPAL_INVESTIGATOR · Emory University

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

All patients admitted to the CICU following cardiac surgery for CHD who are \</= 1 year of age and/or weight \</= 10 kg

Exclusion

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.
  • To compare the effectiveness in avoiding extubation failures of High Flow Nasal Cannula (HFNC) vs Non-Invasive Positive Pressure Ventilation (NIPPV)After surgery up to 2 weeks

    Rates of extubation failures (EF) will be compared among both groups. Data will be collected from the hospital electronic medical record system.