Comparison of RAM Cannula Nasal Continuous Positive Airwa... | NCT02032511

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

NCT02032511

Sponsor

University of Michigan

Status

Terminated

Last Update Posted

Jan 9, 2017Estimated

Enrollment

19Actual

Phase

Not provided

Conditions

Acute Respiratory Deficiency
Prematurity
Assisted Ventilation

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No appreciable difference noted between methods of delivery

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Jan 7, 2014

First Submission Date that Met QC Criteria

Jan 9, 2014

First Posted Date

Jan 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2017

Last Update Posted Date

Jan 9, 2017Estimated

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Measure	Description	Time Frame
Number of patients who achieve unassisted breathing		One year

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

6 Months

Standard Ages

Child

Study Population

infants less than or equal to 7kg with an order for nasal continuous positive pressure

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
RAM Cannula Nasal Continuous Positive Airway Pressure
Infant Flow Nasal Continuous Positive Airway Pressure (NCPAP)