Post-extubation Use RAM Cannula Versus Short Binasal Prong Interfaces in Preterm Infants

Ministry of Health, Saudi Arabia

Status: Not yet enrolling

Conditions: Respiratory Distress Syndrome; Premature; Extubation

Treatments: Other: RAM cannula; Other: Short binasal prong

Study type: Interventional

Funder types: Other

Identifiers

NCT07113535

H-03-M-11

Details and patient eligibility

About

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.

Full 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

Enrollment: 90 estimated patients

Sex: All

Ages: 24 hours to 28 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

RAM cannula group

Active Comparator group

Description:

Preterm infants will receive non-invasive ventilation by RAM cannula

Treatment:

Other: RAM cannula

Short binasal prong group

Active Comparator group

Description:

Preterm infants will receive non-invasive ventilation by short binasal prongs

Treatment:

Other: Short binasal prong