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Not yet recruiting NCT07113535

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

No phase Interventional Premature Respiratory Distress Syndrome Extubation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RAM cannula, Short binasal prong.
Who it may be relevant to
Registry conditions: Premature, Respiratory Distress Syndrome, Extubation. Basic parameters: 24 Hours — 28 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Saudi Arabia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

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

Interventions

  • Other RAM cannula
    RAM cannula as an interface for non invasive ventilation in preterm newborns
  • Other Short binasal prong
    Short binasal prong as an interface for non invasive ventilation in preterm newborns

Primary outcome measures

  • Failure of extubation incidence rate [Time frame: 28 days of an infant's life]
Secondary outcome measures (6)
  • Duration of non-invasive ventilation [Time frame: 120 days]
  • whole duration of oxygen therapy [Time frame: 120 days]
  • Diaphragmatic indices and lung ultrasound scores post-extubation (pre & post extubation then weekly) [Time frame: 120 days]
  • Need for reintubation within 7 days [Time frame: 28 days of an infant's life]
  • Bronchopulmonary dysplasia [Time frame: 120 days]
  • Mortality [Time frame: 120 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Saudi Arabia · 1 center
  • King Salman Bin Abdulaziz Medical City — Madinah

Publications

  • 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. PMID 31394948

Identifiers

NCT: NCT07113535 · H-03-M-11

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗