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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

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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

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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Newborn Continuous Positive Airway Pressure Low Birth Weight Infants Device: RAM Cannula Device: Binasal Prong CPAP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Neotech RAM Cannula Versus Conventional Binasal Prong Continuous Positive Airway Pressure (CPAP) to Treat Respiratory Distress in Low Birth Weight Neonates
Study Start Date : June 2014
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017


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



Primary Outcome Measures :
  1. Oxygenation [ Time Frame: 3 hrs ]
    Pulse oximetry

  2. Ventilation [ Time Frame: 3 hrs ]
    transcutaneous carbon dioxide monitor


Secondary Outcome Measures :
  1. Esophageal pressure measurements [ Time Frame: 3 hrs ]
    Esophageal Pressure Catheter

  2. Apnea [ Time Frame: 3 hrs ]
    3-channel pneumogram


Other Outcome Measures:
  1. Pulse [ Time Frame: 3 hrs ]
  2. Respiratory Rate [ Time Frame: 3 hrs ]
  3. Blood Pressure [ Time Frame: 3 hrs ]
  4. Oxygen requirement [ Time Frame: 3 hrs ]
    Measured by fraction of inspired oxygen to maintain target pulse oximetry saturation.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168257


Locations
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United States, Minnesota
Children's Hospitals and Clinics of Minnesota
Saint Paul, Minnesota, United States, 55102
Sponsors and Collaborators
Children's Hospitals and Clinics of Minnesota
Investigators
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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
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Responsible Party: Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT02168257    
Other Study ID Numbers: 1303-032
47575 ( Other Grant/Funding Number: Children's Hospitals and Clinics of Minnesota IRGP )
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Keywords provided by Children's Hospitals and Clinics of Minnesota:
Nasal Cannula
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Body Weight
Birth Weight
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases