Neotech RAM Cannula Versus Conventional Binasal Prong Continuous Positive Airway Pressure (CPAP) to Treat Respiratory Distress in Low Birth Weight Neonates

July 18, 2017 updated by: Children's Hospitals and Clinics of Minnesota
The purpose of this study is to determine if the RAM cannula is as effective as conventional binasal prongs to deliver CPAP to low birth weight infants with respiratory distress.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Saint Paul, Minnesota, United States, 55102
        • Children's Hospitals and Clinics of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Low Birth Weight Infant
  • Currently on continuous positive aireway pressure of 5-7 cm water pressure
  • Receiving continuous positive airway pressure support for > 24 hrs prior to enrollment
  • Fraction of inspired oxygen requirement of 23-50%

Exclusion Criteria:

  • Fraction of inspired oxygen > 50%
  • Congenital defects of head, pulmonary or cardiovascular systems
  • Chromosomal abnormalities/genetic syndromes
  • Invasive Surgical Procedure within 24 hrs prior to enrollment
  • Enrollment in separate clinical trial that has ongoing data collection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RAM Cannula CPAP
CPAP provided by RAM Cannula
Device: RAM Cannula
Active Comparator: Binasal Prong CPAP
CPAP provided by binasal prong
Device: Binasal Prong CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygenation
Time Frame: 3 hrs
Pulse oximetry
3 hrs
Ventilation
Time Frame: 3 hrs
transcutaneous carbon dioxide monitor
3 hrs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Esophageal pressure measurements
Time Frame: 3 hrs
Esophageal Pressure Catheter
3 hrs
Apnea
Time Frame: 3 hrs
3-channel pneumogram
3 hrs

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulse
Time Frame: 3 hrs
3 hrs
Respiratory Rate
Time Frame: 3 hrs
3 hrs
Blood Pressure
Time Frame: 3 hrs
3 hrs
Oxygen requirement
Time Frame: 3 hrs
Measured by fraction of inspired oxygen to maintain target pulse oximetry saturation.
3 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospitals and Clinics of Minnesota

Investigators

  • Principal Investigator: Neil P Mulrooney, MD, Children's Hospitals and Clinics of Minnesota
  • Principal Investigator: Andrea L Lampland, MD, Children's Hospitals and Clinics of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

June 18, 2014

First Submitted That Met QC Criteria

June 19, 2014

First Posted (Estimate)

June 20, 2014

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1303-032
  • 47575 (Other Grant/Funding Number: Children's Hospitals and Clinics of Minnesota IRGP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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