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

Primary Purpose

Respiratory Distress Syndrome, Newborn, Continuous Positive Airway Pressure, Low Birth Weight Infants

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RAM Cannula
Binasal Prong CPAP
Sponsored by
Children's Hospitals and Clinics of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome, Newborn focused on measuring Nasal Cannula

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospitals and Clinics of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RAM Cannula CPAP

Binasal Prong CPAP

Arm Description

CPAP provided by RAM Cannula

CPAP provided by binasal prong

Outcomes

Primary Outcome Measures

Oxygenation
Pulse oximetry
Ventilation
transcutaneous carbon dioxide monitor

Secondary Outcome Measures

Esophageal pressure measurements
Esophageal Pressure Catheter
Apnea
3-channel pneumogram

Full Information

First Posted
June 18, 2014
Last Updated
July 18, 2017
Sponsor
Children's Hospitals and Clinics of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02168257
Brief Title
Neotech RAM Cannula Versus Conventional Binasal Prong Continuous Positive Airway Pressure (CPAP) to Treat Respiratory Distress in Low Birth Weight Neonates
Official Title
Neotech RAM Cannula Versus Conventional Binasal Prong Continuous Positive Airway Pressure (CPAP) to Treat Respiratory Distress in Low Birth Weight Neonates
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
June 2014 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospitals and Clinics of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Newborn, Continuous Positive Airway Pressure, Low Birth Weight Infants
Keywords
Nasal Cannula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RAM Cannula CPAP
Arm Type
Experimental
Arm Description
CPAP provided by RAM Cannula
Arm Title
Binasal Prong CPAP
Arm Type
Active Comparator
Arm Description
CPAP provided by binasal prong
Intervention Type
Device
Intervention Name(s)
RAM Cannula
Intervention Type
Device
Intervention Name(s)
Binasal Prong CPAP
Primary Outcome Measure Information:
Title
Oxygenation
Description
Pulse oximetry
Time Frame
3 hrs
Title
Ventilation
Description
transcutaneous carbon dioxide monitor
Time Frame
3 hrs
Secondary Outcome Measure Information:
Title
Esophageal pressure measurements
Description
Esophageal Pressure Catheter
Time Frame
3 hrs
Title
Apnea
Description
3-channel pneumogram
Time Frame
3 hrs
Other Pre-specified Outcome Measures:
Title
Pulse
Time Frame
3 hrs
Title
Respiratory Rate
Time Frame
3 hrs
Title
Blood Pressure
Time Frame
3 hrs
Title
Oxygen requirement
Description
Measured by fraction of inspired oxygen to maintain target pulse oximetry saturation.
Time Frame
3 hrs

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil P Mulrooney, MD
Organizational Affiliation
Children's Hospitals and Clinics of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrea L Lampland, MD
Organizational Affiliation
Children's Hospitals and Clinics of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospitals and Clinics of Minnesota
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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