Clinical trial

A Supraglottic Instillation Device for Administration of Surfactant in Neonates- A Pilot Study

Name

ProVia-01

Description

A pilot study to explore and determine feasibility and safety of the administration of surfactant through a new supraglottic device in patients from 500 to 5000 grams with RDS.

Trial arms

Trial start

2025-02-07

Estimated PCD

2025-12-12

Trial end

2026-03-12

Phase

Early phase I

Treatment

surfactant airway device

Infants who meet eligibility criteria and have a signed consent form by their parent or guardian will be enrolled in the study. Once enrolled, the surfactant airway device placement and surfactant administration will occur as detailed in the protocol. The infant will be monitored. If the infant meets instillation failure criteria, the procedure will be repeated shortly after the initial procedure. A maximum of two (2) doses will be given during the initial procedure. If the infant meets re-dosing criteria, (s)he may receive up to two (2) additional doses through the surfactant airway device (initial procedure with 1-2 doses and up to two additional doses). If at any time the infant reaches treatment failure criteria, the infant would be intubated and receive a site-specific surfactant through an endotracheal tube. Study outcome data will be followed until discharge from the NICU.

Arms:

Surfactant administered via supraglottic administration device

Size

Primary endpoint

Instillation failures

First 10 minutes after surfactant instillation.

Treatment failure

First 3 days of life

Eligibility criteria

Inclusion Criteria: * Gestational age at the time of enrollment ≥ 24 0/7 weeks * Weight at the time of enrollment 500- 5000 grams * Age ≤ 24 hours old * Require non-invasive respiratory support (i.e. continuous positive airway pressure, high flow nasal cannula or non-invasive ventilation) * Require FiO2 ≤ 40% * Clinical diagnosis of RDS Exclusion Criteria: * Prior surfactant administration * Prior mechanical ventilation * Major congenital anomaly * Abnormality of the airway * Respiratory distress secondary to an etiology other than RDS (suspected pulmonary hypoplasia, pneumothorax, meconium aspiration syndrome, pneumonia, septic or hypovolemia shock, hypoxic ischemic encephalopathy) * Apgar score \< 5 at 5 minutes of age

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pilot Study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 55, 'type': 'ESTIMATED'}}

Updated at

2023-11-01

1 organization

1 product

3 indications

Organization

ONY

Product

Surfactant Airway Device

Indication

Respiratory Distress Syndrome of Prematurity

Indication

Surfactant Protein B Deficiency

Indication

Chronic Obstructive Pulmonary Disease