NCT01531465

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2011

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
9 months until next milestone

First Posted

Study publicly available on registry

February 13, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

1.3 years

First QC Date

May 25, 2011

Last Update Submit

June 3, 2013

Conditions

Respiratory Insufficiency

Keywords

Respiratory insufficiencyInfantsHigh Flow Nasal Cannula (HFNC)Nasal Continuous Positive Airway Pressure (NCPAP)

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

HFNC to NCPAP

OTHER

Infants who are currently on HFNC.

Other: Pulmonary function testing and esophageal pressure

NCPAP to HFNC

OTHER

Infants who are currently on NCPAP.

Other: Pulmonary Function Testing & esophageal pressure monitoring

Interventions

Pulmonary Function Testing & esophageal pressure monitoringOTHER

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.

Also known as: Pulmonary Function Testing, Esophageal pressure
NCPAP to HFNC
Pulmonary function testing and esophageal pressureOTHER

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.

Also known as: Pulmonary Function Testing, Esophageal pressure
HFNC to NCPAP

Eligibility Criteria

Age2 Days - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Infants with skeletal or neuromuscular disorders that affect the accuracy of RIP PFT measurements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christiana Care Health System - Christiana Hospital

Newark, Delaware, 19718, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Respiratory Physiological Phenomena

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena

Study Officials

  • Beatriz de Jongh, MD

    Christiana Care Health Systems

    PRINCIPAL INVESTIGATOR

  • Robert Locke, DO

    Christiana Care Health Services

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2011

First Posted

February 13, 2012

Study Start

June 1, 2011

Primary Completion

October 1, 2012

Study Completion

January 1, 2013

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations

US(1)