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NOT YET RECRUITING
NCT07113535
NA

Post-extubation Use RAM Cannula Versus Short Binasal Prong Interfaces in Preterm Infants

Sponsor: Ministry of Health, Saudi Arabia

View on ClinicalTrials.gov

Summary

Nowadays, the use of non-invasive ventilation for preterm infants in the NICU has increased to avoid complications associated with prolonged endotracheal intubation. Adequate pressure delivery through non-invasive ventilation is essential, as it enhances the growth and development of premature lungs. Various interfaces have been used to ensure proper sealing. The RAM cannula, used as an interface for non-invasive respiratory support in preterm neonates, is associated with reduced nasal trauma compared to short binasal prongs (SBPs), due to its softer material, making it a safer option. However, the RAM cannula has been shown to deliver lower pharyngeal pressure and, therefore, may not maintain airway pressure as consistently as nasal prongs. Currently, limited data is available regarding the efficacy of nasal prongs compared to the RAM cannula as a post-extubation interface for non-invasive ventilation support in preterm infants. Additionally, we have observed that the use of the RAM cannula for non-invasive ventilation in preterm infants is associated with a longer duration of oxygen therapy compared to SBPs. The investigators hypothesize that the RAM cannula provides a lower level of positive end-expiratory pressure compared to SBPs during non-invasive ventilation. The investigators aim to assess the efficacy and safety of the RAM cannula versus SBPs as nasal interfaces for post-extubation non-invasive respiratory support in preterm infants.

Official title: RAM Cannula Versus Short Binasal Prong Interfaces of Non- Invasive Ventilation for Prevention of Extubating Failure in Preterm Infants: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

24 Hours - 28 Days

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2025-08

Completion Date

2027-12-31

Last Updated

2025-08-08

Healthy Volunteers

No

Interventions

OTHER

RAM cannula

RAM cannula as an interface for non invasive ventilation in preterm newborns

OTHER

Short binasal prong

Short binasal prong as an interface for non invasive ventilation in preterm newborns

Locations (1)

King Salman Bin Abdulaziz Medical City

Madinah, Saudi Arabia