Extubation, Premature, Respiratory Distress Syndrome
Conditions
Keywords
nasal interface, noninvasive respiratory support, premature, RAM cannula, Chest ultrasound, Diaphragm
Brief 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.
Detailed description
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
Interventions
OTHERRAM cannula
RAM cannula as an interface for non invasive ventilation in preterm newborns
OTHERShort binasal prong
Short binasal prong as an interface for non invasive ventilation in preterm newborns
Sponsors
Ministry of Health, Saudi Arabia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
24 Hours to 28 Days
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Outborn preterm neonates * Major congenital malformations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failure of extubation incidence rate | 28 days of an infant's life | Need for reintubation within 72 hours post-extubation trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| whole duration of oxygen therapy | 120 days | Days on oxygen therapy during NICU admission |
| Diaphragmatic indices and lung ultrasound scores post-extubation (pre & post extubation then weekly) | 120 days | Diaphragmatic indices (diaphragmatic thickness &excursion) and lung ultrasound scores post-extubation |
| Duration of non-invasive ventilation | 120 days | Days on non-invasive ventilation |
| Bronchopulmonary dysplasia | 120 days | — |
| Mortality | 120 days | Pre-discharge mortality |
| Need for reintubation within 7 days | 28 days of an infant's life | Need for reintubation within 72 hours post-extubation trial |
Countries
Saudi Arabia
Contacts
Primary ContactOhoud Almoualled, Dr
Backup ContactNehad Nasef, Dr
Outcome results
None listed