An interventional study of RAM cannula and Short binasal prong in Premature, Respiratory Distress Syndrome and Extubation, sponsored by Ministry of Health, Saudi Arabia. Not yet recruiting at 1 site in Saudi Arabia. Open to participants aged 24 Hours to 28 Days. Per ClinicalTrials.gov, last updated 2025-08-08.
Sponsored by Ministry of Health, Saudi Arabia · Not applicable, Interventional, and Prevention
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 :
Re intubation criteria :
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 90 is close to the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Ministry of Health, Saudi Arabia is the lead sponsor of 21 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Preterm infants will receive non-invasive ventilation by RAM cannula
Other: RAM cannula
Preterm infants will receive non-invasive ventilation by short binasal prongs
Other: Short binasal prong
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
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
Plan to share: Yes — Data obtained through this study may be provided to qualified researchers for research and scientific purposes (i.e conduction of meta-analysis or systematic review). Data or samples shared will be coded, with no protected health information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Supporting information: Study protocol
Time frame: Data requests can be submitted starting 3 months after article publication and the data will be made accessible for up to 12 months. Extensions will be considered on a case-by-case basis
Access criteria: Access to raw data (no protected health information) can be requested by qualified researchers for scientific purposes, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Ministry of Health, Saudi Arabia