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

Not Applicable

Completed

• Conditions: Intubation, Intratracheal; Noninvasive Ventilation; Infant, Premature; Respiratory Distress Syndrome, Newborn
• Interventions: Device: Short nasal prongs; Device: Ram cannula

• Registration Number: NCT03081611
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2017-03-12
• Study First Submitted QC: 2017-03-15
• Study First Posted: 2017-03-16
• Study Start: 2018-01-01
• Primary Completion: 2019-12-30
• Study Completion: 2020-01-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-15
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short nasal prongs	Short nasal prongs	NIPPV VIA short nasal prongs
Ram cannula	Ram cannula	NIPPV VIA Ram cannula

Primary Outcome Measures

Name	Time	Method
intubation	72 hours	The need for intubation

Secondary Outcome Measures

Name	Time	Method
nasal trauma	during NIPPV procedure	nasal trauma

Trial Locations

Locations (1)

Rambam Medical Center; 🇮🇱 Haifa, Israel