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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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAM cannula group | Active Comparator | Preterm infants will receive non-invasive ventilation by RAM cannula |
|
| Short binasal prong group | Active Comparator | Preterm infants will receive non-invasive ventilation by short binasal prongs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAM cannula | Other | RAM cannula as an interface for non invasive ventilation in preterm newborns |
|
| Measure | Description | Time Frame |
|---|---|---|
| Failure of extubation incidence rate | Need for reintubation within 72 hours post-extubation trial | 28 days of an infant's life |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of non-invasive ventilation | Days on non-invasive ventilation | 120 days |
| whole duration of oxygen therapy | Days on oxygen therapy during NICU admission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ohoud Almoualled, Dr | Contact | +966500550679 | o.doc2or@gmail.com | |
| Nehad Nasef, Dr | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Nehad Nasef, Dr | King Salman Bin Abdulaziz Medical City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Salman Bin Abdulaziz Medical City | Madinah | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31394948 | Background | Gokce IK, Kaya H, Ozdemir R. A randomized trial comparing the short binasal prong to the RAM cannula for noninvasive ventilation support of preterm infants with respiratory distress syndrome. J Matern Fetal Neonatal Med. 2021 Jun;34(12):1868-1874. doi: 10.1080/14767058.2019.1651268. Epub 2019 Aug 8. |
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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.
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 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)
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Short binasal prong | Other | Short binasal prong as an interface for non invasive ventilation in preterm newborns |
|
| 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 | 120 days |
| Need for reintubation within 7 days | Need for reintubation within 72 hours post-extubation trial | 28 days of an infant's life |
| Bronchopulmonary dysplasia | 120 days |
| Mortality | Pre-discharge mortality | 120 days |
| D000091642 | Urogenital Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |