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NCT03081611 Clinical Trial

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

Infant, Premature Clinical Trial

— RAMCAN  

Official title:
RAM Cannula for Delivering Nasal Intermittent Positive Pressure Ventilation (NIPPV) in Preterm Infants: Non Inferiority Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03081611
Other study ID # RAMCAN
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date January 30, 2020

Study information
Verified date February 2020
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 166
Est. completion date January 30, 2020
Est. primary completion date December 30, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 28 Days
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Ram cannula
Ventilatory support for preterm infants using Ram cannula
• Short nasal prongs
Ventilatory support for preterm infants using short nasal prongs

Locations
Country Name City State
Israel Rambam Medical Center Haifa

Sponsors (1)
Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary intubation The need for intubation 72 hours
Secondary nasal trauma nasal trauma during NIPPV procedure
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