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

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

Detailed Description
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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.

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

Conditions
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Respiratory Distress Syndrome

Intervention / Treatment
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* Drug: Aerosolized Calfactant
* Device: Solarys


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: RDS Patients NICU patient, ≥1hour of age and <24 hours of age. Clinical diagnosis of RDS, with or without chest X-ray data. Inspired oxygen ≥21% to maintain adequate oxygen saturation. Not intubated Requiring: nasal continuous positive airway pressure (nCPAP). Exclusion Criteria: Congenital anomaly limiting care options or requiring early surgery. Cardiopulmonary decompensation. hypotension with metabolic acidosis (base excess < -10 meq/l). Oxygen saturations < 88% at start of aerosolization. PaCO2 ≥ 60 mmHg at start of aerosolization. Grade 3 or Grade 4 intraventricular hemorrhage by cranial ultrasound, if known. Acute hypoxic encephalopathy with or without seizures.

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 24 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerosolized Calfactant<br>NICU Patients with a clinical diagnosis of RDS Inspired oxygen ≥21% to maintain adequate oxygen saturation Not Intubated Requiring Nasal continuous positive airway pressure | Drug: Aerosolized Calfactant<br>* Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.<br>* Other names: Calfactant;Device: Solarys<br>* Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.<br>|
| No Intervention: Usual Care<br>There will be no protocol driven interventions in the usual care group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation | Incidence of the requirement for endotracheal intubation and instillation of surfactant to usual care. | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | Incidence of death | 28 days | 
| Bronchopulmonary Dysplasia | Incidence of Bronchopulmonary Dysplasia defined as oxygen requirement to maintain acceptable blood oxygenation saturations. | 28 days or discharge | 
| Severity of Acute RDS | Measured by oxygen requirements and respiratory support | Randomization to 72 hours of age or to intubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infasurf, Respiratory Distress Syndrome, RDS, Premature, Neonates, Aerosol, surfactant, calfactant