Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT07113535
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-08
First Post:
2025-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-extubation Use RAM Cannula Versus Short Binasal Prong Interfaces in Preterm Infants
Sponsor:
Ministry of Health, Saudi Arabia
Organization:
Study Overview
Official Title:
RAM Cannula Versus Short Binasal Prong Interfaces of Non- Invasive Ventilation for Prevention of Extubating Failure in Preterm Infants: A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: