- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03081611
RAM Cannula VS Short Nasal Prongs for Delivering NIPPV in Preterm Infants (RAMCAN)
February 15, 2020 updated by: Ori Hochwald , MD, Rambam Health Care Campus
RAM Cannula for Delivering Nasal Intermittent Positive Pressure Ventilation (NIPPV) in Preterm Infants: Non Inferiority Randomized Control Trial
Randomized control trial, Ram cannula VS short nasal prongs for delivering Non Invasive Positive Pressure Ventilation (NIPPV) for preterm infants
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
166
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Haifa, Israel, 31096
- Rambam Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 4 weeks (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Ram cannula
NIPPV VIA Ram cannula
|
Ventilatory support for preterm infants using Ram cannula
|
ACTIVE_COMPARATOR: Short nasal prongs
NIPPV VIA short nasal prongs
|
Ventilatory support for preterm infants using short nasal prongs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
intubation
Time Frame: 72 hours
|
The need for intubation
|
72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
nasal trauma
Time Frame: during NIPPV procedure
|
nasal trauma
|
during NIPPV procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ori Hochwald, MD, NICU, Rambam Medical Center, Haifa, Israel
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2018
Primary Completion (ACTUAL)
December 30, 2019
Study Completion (ACTUAL)
January 30, 2020
Study Registration Dates
First Submitted
March 12, 2017
First Submitted That Met QC Criteria
March 15, 2017
First Posted (ACTUAL)
March 16, 2017
Study Record Updates
Last Update Posted (ACTUAL)
February 18, 2020
Last Update Submitted That Met QC Criteria
February 15, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RAMCAN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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