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

NCT07113535 | Not Yet Recruiting DMC

• 1 other identifier: H-03-M-11
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Premature; Respiratory Distress Syndrome; Extubation

Keywords

nasal interface; noninvasive respiratory support; premature; RAM cannula; Chest ultrasound; Diaphragm

Outcome Measures

Primary Outcomes (1)

• Failure of extubation incidence rate

  Need for reintubation within 72 hours post-extubation trial

  28 days of an infant's life

Secondary Outcomes (6)

• Duration of non-invasive ventilation

  120 days

• whole duration of oxygen therapy

  120 days

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

  120 days

• Need for reintubation within 7 days

  28 days of an infant's life

• Bronchopulmonary dysplasia

  120 days

Study Arms (2)

RAM cannula group

ACTIVE COMPARATOR

Preterm infants will receive non-invasive ventilation by RAM cannula

Other: RAM cannula

Short binasal prong group

ACTIVE COMPARATOR

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

Other: Short binasal prong

Interventions

RAM cannula OTHER

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

RAM cannula group

Short binasal prong OTHER

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

Short binasal prong group

Eligibility Criteria

• Age: 24 Hours - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Outborn preterm neonates
• Major congenital malformations.

Sponsors & Collaborators

• Ministry of Health, Saudi Arabia: lead

Study Sites (1)

King Salman Bin Abdulaziz Medical City

Madinah, Saudi Arabia

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Nehad Nasef, Dr

  King Salman Bin Abdulaziz Medical City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ohoud Almoualled, Dr

CONTACT

+966500550679; o.doc2or@gmail.com

Nehad Nasef, Dr

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow of Neonatal- perinatal medicine, NICU

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 8, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data requests can be submitted starting 3 months after article publication and the data will be made accessible for up to 12 months. Extensions will be considered on a case-by-case basis
• Access Criteria: Access to raw data (no protected health information) can be requested by qualified researchers for scientific purposes, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)

Locations

SA (1)