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

Primary Purpose

Respiratory Distress Syndrome, Newborn, Noninvasive Ventilation, Infant, Premature

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Ram cannula
Short nasal prongs
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome, Newborn

Eligibility Criteria

undefined - 28 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rambam Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ram cannula

Short nasal prongs

Arm Description

NIPPV VIA Ram cannula

NIPPV VIA short nasal prongs

Outcomes

Primary Outcome Measures

intubation
The need for intubation

Secondary Outcome Measures

nasal trauma
nasal trauma

Full Information

First Posted
March 12, 2017
Last Updated
February 15, 2020
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT03081611
Brief Title
RAM Cannula VS Short Nasal Prongs for Delivering NIPPV in Preterm Infants
Acronym
RAMCAN
Official Title
RAM Cannula for Delivering Nasal Intermittent Positive Pressure Ventilation (NIPPV) in Preterm Infants: Non Inferiority Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Newborn, Noninvasive Ventilation, Infant, Premature, Intubation, Intratracheal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Non Inferiority Randomized Control Trial
Masking
None (Open Label)
Masking Description
Not possible
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ram cannula
Arm Type
Experimental
Arm Description
NIPPV VIA Ram cannula
Arm Title
Short nasal prongs
Arm Type
Active Comparator
Arm Description
NIPPV VIA short nasal prongs
Intervention Type
Device
Intervention Name(s)
Ram cannula
Intervention Description
Ventilatory support for preterm infants using Ram cannula
Intervention Type
Device
Intervention Name(s)
Short nasal prongs
Intervention Description
Ventilatory support for preterm infants using short nasal prongs
Primary Outcome Measure Information:
Title
intubation
Description
The need for intubation
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
nasal trauma
Description
nasal trauma
Time Frame
during NIPPV procedure

10. Eligibility

Sex
All
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ori Hochwald, MD
Organizational Affiliation
NICU, Rambam Medical Center, Haifa, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33165539
Citation
Hochwald O, Riskin A, Borenstein-Levin L, Shoris I, Dinur GP, Said W, Jubran H, Littner Y, Haddad J, Mor M, Timstut F, Bader D, Kugelman A. Cannula With Long and Narrow Tubing vs Short Binasal Prongs for Noninvasive Ventilation in Preterm Infants: Noninferiority Randomized Clinical Trial. JAMA Pediatr. 2021 Jan 1;175(1):36-43. doi: 10.1001/jamapediatrics.2020.3579.
Results Reference
derived

Learn more about this trial

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

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