High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure

Study Overview
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Brief Summary
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The purpose of this study is to compare two common methods of providing respiratory support: nasal continuous airway pressure and high flow nasal cannula to see what effect it has on babies breathing. The investigators also will compare the effects of slightly changing the level of support these two different types of therapy on how easily your baby is breathing. Changes in the level of support and between these two respiratory support modalities are frequently done and are part of the routine care in the neonatal intensive care unit.

Official Title
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Pulmonary Function Testing in Infants With Respiratory Insufficiency While Receiving High Flow Nasal Cannula (HFNC) Versus Nasal Continuous Positive Airway Pressure (nCPAP)

Conditions
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Respiratory Insufficiency

Intervention / Treatment
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* Other: Pulmonary Function Testing & esophageal pressure monitoring
* Other: Pulmonary function testing and esophageal pressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants who are between 28 and 40 weeks of corrected gestational age at the time of study entry Currently on high flow nasal cannula receiving 3 to 5 lpm or on nasal continuous positive airway pressure at 5 to 6 cmH2P with and FiO2 requirement </= 40% by the clinical care team for clinical care purposes. On current mode of support for >/= 12 hours and have been extubated from a mechanical ventilator for >/= 48 hours. Exclusion Criteria: Infants with skeletal or neuromuscular disorders that affect the accuracy of RIP PFT measurements.

Ages Eligible for Study
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Minimum Age: 2 Days
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HFNC to NCPAP<br>Infants who are currently on HFNC. | Other: Pulmonary function testing and esophageal pressure<br>* Infants who are currently on HFNC will have pulmonary function testing (PFTs) and esophageal pressure performed while on 2 different settings of HFNC. These infants will then be transitioned NCPAP and will undergo PFTs and esophageal pressure while on 2 different NCPAP settings. The infant will then be returned to HFNC at the same settings they were on prior to any study interventions.<br>* Other names: Esophageal pressure;|
| Other: NCPAP to HFNC<br>Infants who are currently on NCPAP. | Other: Pulmonary Function Testing & esophageal pressure monitoring<br>* Infants who are currently on NCPAP will have pulmonary function testing (PFTs)and esophageal pressure performed while on 2 different settings of NCPAP. These infants will then be transitioned HFNC and will undergo PFTs and esophageal pressure while on different HFNC settings. The infant will then be returned to NCPAP at the same settings they were on prior to any study interventions.<br>* Other names: Esophageal pressure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lung compliance | Is there a difference in pulmonary function tests in infants with respiratory insufficiency being treated with high flow nasal cannula (HFNC) or nasal continuous positive airway pressure (NCPAP)? | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory insufficiency, Infants, High Flow Nasal Cannula (HFNC), Nasal Continuous Positive Airway Pressure (NCPAP)