InfasurfAero™ Versus Sham Treatment in Preterm Newborns with RDS (Aero-05)

ONY

Status and phase: Enrolling; Phase 3

Conditions: Death; Neonatal; Respiratory Distress Syndrome (Neonatal); Intubation Complication

Treatments: Combination Product: Infasurf Aero™

Study type: Interventional

Funder types: Industry

Identifiers

NCT05960929

AERO-05 Protocol

Details and patient eligibility

About

The purpose of this clinical study is to determine the effectiveness and safety of Infasurf® administered through the InfasurfAero™, a novel oral airway delivery device specifically designed to give Infasurf in a less complicated way and without the need for a breathing tube or interrupting nasal respiratory support.

Full description

This single-dose, double-blind, random allocation, sham-control, clinical trial will recruit spontaneously breathing newborns with RDS stable on non-invasive nasal respiratory support. Enrolled clinical study subjects will be randomly allocated to receive respiratory air with Infasurf® (Intervention Arm) or respiratory air alone (Sham Control Arm) through the InfasurfAero™.

The objectives of this clinical study are to i) assess the effectiveness of a single dose of Infasurf administered through the InfasurfAero in preventing CPAP failure, and ii) assess the safety of Infasurf administered through the InfasurfAero.

Subjects will be enrolled at one of 10+ sites. 7 sites are currently recruited.

Enrollment: 220 estimated patients

Sex: All

Ages: 29 to 36 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

Inclusion criteria include ALL of the following:

1. Written informed consent obtained by parent or legal representative prior to or after birth
2. Gestational age at birth ≥ 29 0/7 AND ≤ 35 6/7 weeks
3. Birthweight ≥ 1,000 AND ≤ 3,500 grams
4. Age ≥ 1 hour AND ≤ 6 hours
5. Clinical diagnosis of surfactant-deficient RDS, with EITHER i. a Silverman-Anderson Retraction Score ≥ 5 (in Room Air), OR ii. signs of respiratory distress (tachypnea, retractions, grunting) AND radiographic confirmation
6. Require CPAP
7. Respiratory Severity Score (RSS) ≥ 1.25 AND ≤ 2.4
8. If subject is >346/7 weeks' gestation a chest radiograph is required

Exclusion criteria

Exclusion criteria are ANY of the following:

1. Surfactant administration prior to randomization
2. Mechanical ventilation prior to randomization
3. Major congenital anomaly (suspected or confirmed)
4. Abnormality of the airway (suspected or confirmed)
5. Respiratory distress presumed secondary to an etiology other than RDS (e.g., suspected pulmonary hypoplasia, pneumothorax, meconium aspiration syndrome, pneumonia, septic or hypovolemia shock, hypoxic ischemic encephalopathy)
6. Apgar score < 3 at 5 minutes of age
7. Umbilical cord gas pH <7.0 or BD > 10
8. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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220 participants in 2 patient groups

Treatment Arm

Experimental group

Description:

A single dose of Calfactant at 6ml/kg administered via the Infasurf Aero™ Nebulizer until completion.

Treatment:

Combination Product: Infasurf Aero™

Control Arm

Sham Comparator group

Description:

Low flow respiratory air alone through the InfasurfAero™ Nebulizer until completion.

Treatment:

Combination Product: Infasurf Aero™