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RAM Cannula VS Short Nasal Prongs for Delivering NIPPV in Preterm Infants (RAMCAN)

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ClinicalTrials.gov Identifier: NCT03081611
Recruitment Status : Not yet recruiting
First Posted : March 16, 2017
Last Update Posted : March 16, 2017
Sponsor:
Information provided by (Responsible Party):
Ori Hochwald , MD, Rambam Health Care Campus

Brief Summary:
Randomized control trial, Ram cannula VS short nasal prongs for delivering Non Invasive Positive Pressure Ventilation (NIPPV) for preterm infants

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Newborn Noninvasive Ventilation Infant, Premature Intubation, Intratracheal Device: Ram cannula Device: Short nasal prongs Not Applicable

Detailed Description:
Randomized control trial comparing Ram cannula to the regular, more investigated short nasal prongs for delivering Non Invasive Positive Pressure Ventilation (NIPPV) for preterm infants with respiratory distress.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non Inferiority Randomized Control Trial
Masking: None (Open Label)
Masking Description: Not possible
Primary Purpose: Treatment
Official Title: RAM Cannula for Delivering Nasal Intermittent Positive Pressure Ventilation (NIPPV) in Preterm Infants: Non Inferiority Randomized Control Trial
Estimated Study Start Date : April 1, 2017
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : May 31, 2019


Arm Intervention/treatment
Experimental: Ram cannula
NIPPV VIA Ram cannula
Device: Ram cannula
Ventilatory support for preterm infants using Ram cannula

Active Comparator: Short nasal prongs
NIPPV VIA short nasal prongs
Device: Short nasal prongs
Ventilatory support for preterm infants using short nasal prongs




Primary Outcome Measures :
  1. intubation [ Time Frame: 72 hours ]
    The need for intubation


Secondary Outcome Measures :
  1. nasal trauma [ Time Frame: during NIPPV procedure ]
    nasal trauma



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

Inclusion Criteria:

  • Gestational age 24-33.6
  • Physician decision on the need for non invasive ventilation
  • parental consent

Exclusion Criteria:

  • Pneumothorax before recruitment
  • Significant congenital heart disease or chromosomal disorder

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): NCT03081611


Contacts
Contact: Ori Hochwald, MD 97247774111 o_hochwald@rambam.health.gov.il
Contact: NICU Any Neonatologist, MD 97247774111 o_hochwald@rambam.health.gov.il

Locations
Israel
Rambam Medical Center
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Ori Hochwald, MD NICU, Rambam Medical Center, Haifa, Israel

Responsible Party: Ori Hochwald , MD, Principal Investigator, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03081611     History of Changes
Other Study ID Numbers: RAMCAN
First Posted: March 16, 2017    Key Record Dates
Last Update Posted: March 16, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases