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

  • Israel
      • 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
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

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

Rambam Health Care Campus

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.

General Publications

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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