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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2027-12-31

Brief Summary

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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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Detailed Description

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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

Conditions

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Premature Respiratory Distress Syndrome Extubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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RAM cannula group

Preterm infants will receive non-invasive ventilation by RAM cannula

Group Type ACTIVE_COMPARATOR

RAM cannula

Intervention Type OTHER

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

Short binasal prong group

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

Group Type ACTIVE_COMPARATOR

Short binasal prong

Intervention Type OTHER

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

Interventions

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RAM cannula

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

Intervention Type OTHER

Short binasal prong

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

Intervention Type OTHER

Eligibility Criteria

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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.