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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03081611
• Date of registration: 12/03/2017
• Prospective Registration: Yes
• Primary sponsor: Rambam Health Care Campus
• Public title: RAM Cannula VS Short Nasal Prongs for Delivering NIPPV in Preterm Infants RAMCAN
• Scientific title: RAM Cannula for Delivering Nasal Intermittent Positive Pressure Ventilation (NIPPV) in Preterm Infants: Non Inferiority Randomized Control Trial
• Date of first enrolment: January 1, 2018
• Target sample size: 166
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03081611
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Israel

Contacts

• Name: Ori Hochwald, MD
• Affiliation: NICU, Rambam Medical Center, Haifa, Israel

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: 28 Days
Gender: All

Health Condition(s) or Problem(s) studied

Infant, Premature

Intubation, Intratracheal

Noninvasive Ventilation

Respiratory Distress Syndrome, Newborn

Intervention(s)

Device: Short nasal prongs

Device: Ram cannula

Primary Outcome(s)

intubation [Time Frame: 72 hours]

Secondary Outcome(s)

nasal trauma [Time Frame: during NIPPV procedure]

Secondary ID(s)

RAMCAN

Source(s) of Monetary Support

Please refer to primary and secondary sponsors