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NCT02032511 Clinical Trial

Comparison of RAM Cannula Nasal Continuous Positive Airway Pressure Versus Infant Flow Nasal Continuous Positive Airway Pressure (NCPAP)

Prematurity Clinical Trial

Official title:
Comparison of RAM Cannula NCPAP Versus Infant Flow NCPAP

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02032511
Other study ID # HUM00073557
Secondary ID
Status Terminated
Phase N/A
First received January 7, 2014
Last updated January 5, 2017
Start date September 2013
Est. completion date April 2014

Study information
Verified date January 2017
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This study is designed to compare the effectiveness and ease of use of two commonly used NCPAP interfaces: the RAM NC and the Infant Flow prongs and nasal mask.

Recruitment information / eligibility
Status Terminated
Enrollment 19
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender All
Age group N/A to 6 Months
Eligibility Inclusion Criteria:

- less than or equal to 7 kg

- order for nasal continuous positive pressure

Exclusion Criteria:

- patients greater than 7kg

- patients that do not have informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Michigan

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients who achieve unassisted breathing One year No
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