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A Study to Evaluate the Use of the Neotech RAM Nasal Cannula for CPAP and Bi-PAP Application in Infants 28-42 Weeks Gestation in a Neonatal Intensive Care Unit (NICU)

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ClinicalTrials.gov Identifier: NCT04096235
Recruitment Status : Not yet recruiting
First Posted : September 19, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Englewood Hospital and Medical Center

Brief Summary:
This study will explore the RAM Nasal Cannula as a means of providing CPAP and Bi-PAP to infants 28-42 weeks gestation to prevent nasal septal erosion.

Condition or disease Intervention/treatment Phase
Neonatal Respiratory Distress Other: RAM Nasal Cannula Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate the Use of the Neotech RAM Nasal Cannula for CPAP and Bi-PAP Application in Infants 28-42 Weeks Gestation in a Neonatal Intensive Care Unit (NICU)
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020


Arm Intervention/treatment
Experimental: RAM Cannula Other: RAM Nasal Cannula
The RAM Nasal Cannula is a means of providing CPAP and Bi-PAP to infants 28-42 weeks gestation to prevent nasal septal erosion.




Primary Outcome Measures :
  1. NCPAP [ Time Frame: 5 days ]
    The study will determine if the RAM Nasal Cannula is providing adequate CPAP to neonates. This will be measured with the Braden Q score. The Braden Q Scale is composed of seven subscales. All seven subscales are rated from 1 (least favorable)to4(most favorable); patients receive only one score per subscale.

  2. Bi-PAP [ Time Frame: 5 days ]
    The study will determine if the RAM Nasal Cannula is providing adequate Bi-PAP to neonates. This will be measured with the Braden Q score every 3 hours. The Braden Q Scale is composed of seven subscales. All seven subscales are rated from 1 (least favorable)to4(most favorable); patients receive only one score per subscale.

  3. NCPAP [ Time Frame: 5 days ]
    The study will determine if the RAM Nasal Cannula is providing adequate CPAP to neonates. This will be measured with SpO2 Level every 3 hours. The SpO2 will be measured in percentage

  4. NCPAP [ Time Frame: 5 days ]
    The study will determine if the RAM Nasal Cannula is providing adequate CPAP to neonates. This will be measured with Pulse Oximetry Level every 3 hours. The pulse oximetry is measured in millimeters

  5. Bi-PAP [ Time Frame: 5 days ]
    The study will determine if the RAM Nasal Cannula is providing adequate Bi-PAP to neonates. This will be measured with SpO2 Level every 3 hours. The SpO2 will be measured in percentage

  6. Bi-PAP [ Time Frame: 5 days ]
    The study will determine if the RAM Nasal Cannula is providing adequate Bi-PAP to neonates. This will be measured with Pulse Oximetry Level every 3 hours. The pulse oximetry is measured in millimeters


Secondary Outcome Measures :
  1. High Flow Humidity [ Time Frame: 5 days ]
    The study will determine if the RAM Nasal Cannula administers high flow humidity (>8Ipm) . This will be measured with the Braden Q score, every 3 hours.The Braden Q Scale is composed of seven subscales. All seven subscales are rated from 1 (least favorable)to4(most favorable); patients receive only one score per subscale.

  2. High Flow Humidity [ Time Frame: 5 days ]
    The study will determine if the RAM Nasal Cannula administers high flow humidity (>8Ipm) . This will be measured with Pulse Oximetry Level every 3 hours. The pulse oximetry is measured in millimeters.

  3. High Flow Humidity [ Time Frame: 5 days ]
    The study will determine if the RAM Nasal Cannula administers high flow humidity (>8Ipm) . This will be measured with SpO2 Level every 3 hours. The SpO2 will be measured in percentage



Information from the National Library of Medicine

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Ages Eligible for Study:   28 Weeks to 42 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • Infants with birth weight < 1500 grams AND/OR <32 weeks gestational age
  • Infants between 34-42 weeks gestational age and exclusive breastfeeding with no risk of nasal septal erosion OR Infants between 28-42 weeks gestational age at risk of nasal septal erosion

Exclusion:

  • Infants with major congenital and upper airway anomalies
  • Infants requiring ETT (endotracheal tube) mechanical ventilation
  • Infants receiving no respiratory support

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): NCT04096235


Contacts
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Contact: Elizabeth Carlin, MD 201-894-3472 Elizabeth.Carlin@EHMCHealth.org

Sponsors and Collaborators
Englewood Hospital and Medical Center

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Responsible Party: Englewood Hospital and Medical Center
ClinicalTrials.gov Identifier: NCT04096235     History of Changes
Other Study ID Numbers: E-19-763
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases