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.
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 : * Birth weight \< 1000 gram :MAP \<7 cmH2O and FIO2 \<0.30 * Birth weight\>1000 gram :MAP \>8 cmH2O and FIO2 \<0.30 Re intubation criteria : * FIO2\>0.60 to maintain SaO2 \>88% OR PaO2 \> 45 mmHg * PaCO2 {arterial} \> 55-60 with PH \< 7.25 * Apnea and requiring bag and mask ventilation * Evidence of increased work of breathing {retractions -grunting -chest wall distortion } plus abnormal chest x ray
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
90
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
King Salman Bin Abdulaziz Medical City
Madinah, Saudi Arabia
Failure of extubation incidence rate
Need for reintubation within 72 hours post-extubation trial
Time frame: 28 days of an infant's life
Duration of non-invasive ventilation
Days on non-invasive ventilation
Time frame: 120 days
whole duration of oxygen therapy
Days on oxygen therapy during NICU admission
Time frame: 120 days
Diaphragmatic indices and lung ultrasound scores post-extubation (pre & post extubation then weekly)
Diaphragmatic indices (diaphragmatic thickness \&excursion) and lung ultrasound scores post-extubation
Time frame: 120 days
Need for reintubation within 7 days
Need for reintubation within 72 hours post-extubation trial
Time frame: 28 days of an infant's life
Bronchopulmonary dysplasia
Time frame: 120 days
Mortality
Pre-discharge mortality
Time frame: 120 days
Nehad Nasef, Dr
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