King Salman Bin Abdulaziz Medical City
Madinah, Saudi Arabia
NCT Number: NCT07113535
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.
Trial opening soon.
Get Notified24 hour–28 day
All sexes
Interventional
Not applicable
Madinah, Saudi Arabia
Preterm infants will be randomized to receive post-extubation non invasive respiratory support either through RAM cannula or SBPs. Neonates in both groups will be uniformly managed as per unit protocol as following:
Extubation criteria :
Re intubation criteria :
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
RAM cannula as an interface for non invasive ventilation in preterm newborns
Short binasal prong as an interface for non invasive ventilation in preterm newborns
Time frame: 28 days of an infant's life
Need for reintubation within 72 hours post-extubation trial
Time frame: 120 days
Days on non-invasive ventilation
Time frame: 120 days
Days on oxygen therapy during NICU admission
Time frame: 120 days
Diaphragmatic indices (diaphragmatic thickness &excursion) and lung ultrasound scores post-extubation
Time frame: 28 days of an infant's life
Need for reintubation within 72 hours post-extubation trial
Time frame: 120 days
Time frame: 120 days
Pre-discharge mortality
Contact information is provided by the study sponsor or research team.
Ministry of Health, Saudi Arabia
Other Gov
RAM Cannula Versus Short Binasal Prong Interfaces of Non- Invasive Ventilation for Prevention of Extubating Failure in Preterm Infants: A Randomized Controlled Trial
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