Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168257
Recruitment Status : Terminated (Lack of enrollment)
First Posted : June 20, 2014
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Children's Hospitals and Clinics of Minnesota

Tracking Information
First Submitted Date  ICMJE June 18, 2014
First Posted Date  ICMJE June 20, 2014
Last Update Posted Date July 21, 2017
Study Start Date  ICMJE June 2014
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2014)
  • Oxygenation [ Time Frame: 3 hrs ]
    Pulse oximetry
  • Ventilation [ Time Frame: 3 hrs ]
    transcutaneous carbon dioxide monitor
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2014)
  • Esophageal pressure measurements [ Time Frame: 3 hrs ]
    Esophageal Pressure Catheter
  • Apnea [ Time Frame: 3 hrs ]
    3-channel pneumogram
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 21, 2014)
  • Pulse [ Time Frame: 3 hrs ]
  • Respiratory Rate [ Time Frame: 3 hrs ]
  • Blood Pressure [ Time Frame: 3 hrs ]
  • Oxygen requirement [ Time Frame: 3 hrs ]
    Measured by fraction of inspired oxygen to maintain target pulse oximetry saturation.
Original Other Pre-specified Outcome Measures
 (submitted: June 19, 2014)
  • Pulse [ Time Frame: 3 hrs ]
  • Respiratory Rate [ Time Frame: 3 hrs ]
  • Blood Pressure [ Time Frame: 3 hrs ]
  • Oxygen requirement [ Time Frame: 3 hrs ]
 
Descriptive Information
Brief Title  ICMJE Neotech RAM Cannula Versus Conventional Binasal Prong Continuous Positive Airway Pressure (CPAP) to Treat Respiratory Distress in Low Birth Weight Neonates
Official Title  ICMJE Neotech RAM Cannula Versus Conventional Binasal Prong Continuous Positive Airway Pressure (CPAP) to Treat Respiratory Distress in Low Birth Weight Neonates
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Respiratory Distress Syndrome, Newborn
  • Continuous Positive Airway Pressure
  • Low Birth Weight Infants
Intervention  ICMJE
  • Device: RAM Cannula
  • Device: Binasal Prong CPAP
Study Arms  ICMJE
  • Experimental: RAM Cannula CPAP
    CPAP provided by RAM Cannula
    Intervention: Device: RAM Cannula
  • Active Comparator: Binasal Prong CPAP
    CPAP provided by binasal prong
    Intervention: Device: Binasal Prong CPAP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 18, 2017)
8
Original Estimated Enrollment  ICMJE
 (submitted: June 19, 2014)
30
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02168257
Other Study ID Numbers  ICMJE 1303-032
47575 ( Other Grant/Funding Number: Children's Hospitals and Clinics of Minnesota IRGP )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Children's Hospitals and Clinics of Minnesota
Study Sponsor  ICMJE Children's Hospitals and Clinics of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Children's Hospitals and Clinics of Minnesota
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP