NCT02032511

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2013

Shorter than P25 for all trials

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

January 9, 2017

Status Verified

January 1, 2017

Enrollment Period

7 months

First QC Date

January 7, 2014

Last Update Submit

January 5, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of patients who achieve unassisted breathing

    One year

Study Arms (2)

RAM Cannula Nasal Continuous Positive Airway Pressure

Infant Flow Nasal Continuous Positive Airway Pressure (NCPAP)

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • less than or equal to 7 kg
  • order for nasal continuous positive pressure

You may not qualify if:

  • patients greater than 7kg
  • patients that do not have informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RRT

Study Record Dates

First Submitted

January 7, 2014

First Posted

January 10, 2014

Study Start

September 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

January 9, 2017

Record last verified: 2017-01