Administration of Surfactant Through an Instillation Device Infasurf® (Calfactant) in Neonates- A Pilot Study

ONY

Status and phase

Suspended

Phase 2

Conditions

Chronic Lung Disease

RDS of Prematurity

Surfactant Protein B Deficiency

Treatments

Combination Product: surfactant airway device

Study type

Interventional

Funder types

Industry

Identifiers

NCT04056741

ProVia-01

Details and patient eligibility

About

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.

Full description

Surfactant therapy can be life-saving for newborn infants with respiratory distress due to surfactant insufficiency, also known as respiratory distress syndrome (RDS). All commercially available surfactants for clinical use are approved for administration through an endotracheal tube. Placement of an endotracheal tube, a procedure called intubation, is stressful for the infant and associated with significant adverse effects. The proposed supraglottic instillation device allows infants to benefit from surfactant therapy while avoiding the negative effects of intubation.

Enrollment

55 estimated patients

Sex

All

Ages

24+ weeks old

Volunteers

No Healthy Volunteers

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