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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age24-28
SponsorMinistry of Health, Saudi Arabia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Outborn preterm neonates

Major congenital malformations.

Trial design

Design model

Parallel

Treatments tested in this trial

  • RAM cannula

    Other intervention

    RAM cannula as an interface for non invasive ventilation in preterm newborns

  • Short binasal prong

    Other intervention

    Short binasal prong as an interface for non invasive ventilation in preterm newborns

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: RAM cannula groupActive comparator 1 intervention
Group B: Short binasal prong groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Failure of extubation incidence rate

Need for reintubation within 72 hours post-extubation trial

Time frame
28 days of an infant's life

Secondary outcomes

1

Duration of non-invasive ventilation

Days on non-invasive ventilation

Time frame
120 days
2

whole duration of oxygen therapy

Days on oxygen therapy during NICU admission

Time frame
120 days
3

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
4

Need for reintubation within 7 days

Need for reintubation within 72 hours post-extubation trial

Time frame
28 days of an infant's life

Other outcomes

Sponsors and contacts

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