High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure

Respiratory Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01531465
• Other study ID #: 31073
• Status: Completed
• Phase: N/A
• First received: May 25, 2011
• Last updated: June 3, 2013
• Start date: June 2011
• Est. completion date: January 2013

Study information

• Verified date: June 2013
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Other:
• Pulmonary 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.
• Pulmonary 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.

Locations

Country	Name	City	State
United States	Christiana Care Health System - Christiana Hospital	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No