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High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01531465
Enrollment
20
Registered
2012-02-13
Start date
2011-06-30
Completion date
2013-01-31
Last updated
2013-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Insufficiency

Keywords

Respiratory insufficiency, Infants, High Flow Nasal Cannula (HFNC), Nasal Continuous Positive Airway Pressure (NCPAP)

Brief summary

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.

Interventions

OTHERPulmonary Function Testing & esophageal pressure monitoring

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.

OTHERPulmonary function testing and esophageal pressure

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.

Sponsors

Christiana Care Health Services
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Days to 6 Months
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
lung compliance2 hoursIs 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)?

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026