About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Inborn preterm neonates ≤ 32 weeks of gestational and/or birth weight ≤1500 g with respiratory distress syndrome requiring initial invasive ventilation support for at least 24 hours.
Disqualifiers
Outborn preterm neonates
Major congenital malformations.
Trial design
Parallel
Treatments tested in this trial
RAM cannula
Other interventionRAM cannula as an interface for non invasive ventilation in preterm newborns
Short binasal prong
Other interventionShort binasal prong as an interface for non invasive ventilation in preterm newborns
Treatment groups
Trial outcomes
Primary outcomes
Failure of extubation incidence rate
Need for reintubation within 72 hours post-extubation trial
Secondary outcomes
Duration of non-invasive ventilation
Days on non-invasive ventilation
whole duration of oxygen therapy
Days on oxygen therapy during NICU admission
Diaphragmatic indices and lung ultrasound scores post-extubation (pre & post extubation then weekly)
Diaphragmatic indices (diaphragmatic thickness \&excursion) and lung ultrasound scores post-extubation
Need for reintubation within 7 days
Need for reintubation within 72 hours post-extubation trial
Sponsors and contacts
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