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NCT Number: NCT07113535

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

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.

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Key information

Age range

24 hour–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Salman Bin Abdulaziz Medical City

Madinah, Saudi Arabia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RAM cannula

Other

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

Short binasal prong

Other

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

Primary outcomes

  1. Failure of extubation incidence rate

    Time frame: 28 days of an infant's life

    Need for reintubation within 72 hours post-extubation trial

Secondary outcomes

  1. Duration of non-invasive ventilation

    Time frame: 120 days

    Days on non-invasive ventilation

  2. whole duration of oxygen therapy

    Time frame: 120 days

    Days on oxygen therapy during NICU admission

  3. Diaphragmatic indices and lung ultrasound scores post-extubation (pre & post extubation then weekly)

    Time frame: 120 days

    Diaphragmatic indices (diaphragmatic thickness &excursion) and lung ultrasound scores post-extubation

  4. Need for reintubation within 7 days

    Time frame: 28 days of an infant's life

    Need for reintubation within 72 hours post-extubation trial

  5. Bronchopulmonary dysplasia

    Time frame: 120 days

  6. Mortality

    Time frame: 120 days

    Pre-discharge mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Nehad Nasef, Dr

CONTACT

Ohoud Almoualled, Dr

CONTACT

[email protected]

+966500550679

Sponsors and collaborators

Lead sponsor

Ministry of Health, Saudi Arabia

Other Gov

Registry information

Official study title

RAM Cannula Versus Short Binasal Prong Interfaces of Non- Invasive Ventilation for Prevention of Extubating Failure in Preterm Infants: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 8, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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