High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure

Sponsor

Christiana Care Health Services (Other)

Overall Status

Completed

CT.gov ID

NCT01531465

Collaborator

(none)

Enrollment

Location

Arms

19.1

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Insufficiency	Other: Pulmonary Function Testing & esophageal pressure monitoring Other: Pulmonary function testing and esophageal pressure	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: HFNC to NCPAP Infants who are currently on HFNC.	Other: 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. Other Names: Pulmonary Function Testing Esophageal pressure
Other: NCPAP to HFNC Infants who are currently on NCPAP.	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. Other Names: Pulmonary Function Testing Esophageal pressure

Arm

Intervention/Treatment

Other: HFNC to NCPAP

Infants who are currently on HFNC.

Other: 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.

Other Names:

Pulmonary Function Testing

Esophageal pressure

Other: NCPAP to HFNC

Infants who are currently on NCPAP.

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.

Other Names:

Pulmonary Function Testing

Esophageal pressure

Outcome Measures

Primary Outcome Measures

lung compliance [2 hours]
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)?

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Days to 6 Months

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Christiana Care Health System - Christiana Hospital	Newark	Delaware	United States	19718

Sponsors and Collaborators

Christiana Care Health Services

Investigators

Principal Investigator: Beatriz de Jongh, MD, Christiana Care Health Systems
Study Director: Robert Locke, DO, Christiana Care Health Services

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Christiana Care Health Services

ClinicalTrials.gov Identifier:

NCT01531465

Other Study ID Numbers:

31073

First Posted:

Feb 13, 2012

Last Update Posted:

Jun 4, 2013

Last Verified:

Jun 1, 2013

Keywords provided by Christiana Care Health Services

Respiratory insufficiency

Infants

High Flow Nasal Cannula (HFNC)

Nasal Continuous Positive Airway Pressure (NCPAP)

Additional relevant MeSH terms:

Respiratory Insufficiency

Study Results

No Results Posted as of Jun 4, 2013