Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients

ONY

Status and phase: Completed; Phase 3

Conditions: Respiratory Distress Syndrome

Treatments: Drug: Aerosolized Calfactant; Device: Solarys

Study type: Interventional

Funder types: Industry

Identifiers

NCT03058666

Aero-02

Details and patient eligibility

About

Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.

Full description

Treatment will not be masked. The study objective is to document that aerosolized Infasurf is superior to "usual care" and provides for some patients effective surfactant therapy with less need for endotracheal intubation and instillation of a surfactant suspension into the airway. Two cohorts will be recruited: (a) patients who did not receive surfactant at birth who develop RDS in the first hours of life and (b) patients who received instillation of surfactant for RDS in the first hour of life, were extubated, and have continuing RDS.

Enrollment: 477 patients

Sex: All

Ages: 1 to 24 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

RDS Patients

1. NICU patient, ≥1hour of age and <24 hours of age.

2. Clinical diagnosis of RDS, with or without chest X-ray data.

3. Inspired oxygen ≥21% to maintain adequate oxygen saturation.

4. Not intubated

5. Requiring:

   1. nasal continuous positive airway pressure (nCPAP).

Exclusion criteria

1. Congenital anomaly limiting care options or requiring early surgery.

2. Cardiopulmonary decompensation.

   1. hypotension with metabolic acidosis (base excess < -10 meq/l).
   2. Oxygen saturations < 88% at start of aerosolization.
   3. PaCO2 ≥ 60 mmHg at start of aerosolization.

3. Grade 3 or Grade 4 intraventricular hemorrhage by cranial ultrasound, if known.

4. Acute hypoxic encephalopathy with or without seizures.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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477 participants in 2 patient groups

Aerosolized Calfactant

Experimental group

Description:

1. NICU Patients with a clinical diagnosis of RDS 2. Inspired oxygen ≥21% to maintain adequate oxygen saturation 3. Not Intubated 4. Requiring Nasal continuous positive airway pressure

Treatment:

Device: Solarys

Drug: Aerosolized Calfactant

Usual Care

No Intervention group

Description:

There will be no protocol driven interventions in the usual care group.