High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure

NCT ID: NCT01531465

Last Updated: 2013-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-01-31

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.

Detailed Description

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Conditions

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Respiratory Insufficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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HFNC to NCPAP

Infants who are currently on HFNC.

Group Type OTHER

Pulmonary function testing and esophageal pressure

Intervention Type OTHER

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.

NCPAP to HFNC

Infants who are currently on NCPAP.

Group Type OTHER

Pulmonary Function Testing & esophageal pressure monitoring

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Pulmonary Function Testing Esophageal pressure Pulmonary Function Testing Esophageal pressure

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.
Minimum Eligible Age

2 Days

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Christiana Care Health Services

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beatriz de Jongh, MD

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Systems

Robert Locke, DO

Role: STUDY_DIRECTOR

Christiana Care Health Services

Locations

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Christiana Care Health System - Christiana Hospital

Newark, Delaware, United States

Site Status

Countries

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United States

Other Identifiers

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31073

Identifier Type: -

Identifier Source: org_study_id

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