Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants

Study Overview
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Brief Summary
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To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress syndrome (RDS) in premature infants.

Detailed Description
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Use of a device in the early treatment of RDS that permits the effective aerosolization of an exogenous surfactant that also allows for the simultaneous delivery of continuous positive airway pressure would permit the delivery of surfactant to the distal airways without intubation. This approach could reduce the frequency of severity of the adverse events relative to endotracheal intubation and surfactant administration via bolus.

Official Title
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An Open Label, Multicenter, Phase 2, Pilot Evaluation of SURFAXIN®(Lucinactant) Delivered as an Aerosol Via Nasal Continuous Positive Airway Pressure (nCPAP) in the Prevention of Respiratory Distress Syndrome in Premature Infants

Conditions
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Respiratory Distress Syndrome

Intervention / Treatment
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* Drug: Aerosolized lucinactant
* Drug: Aerosolized lucinactant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age 28-32 completed weeks, inclusive Placement of arterial line Successful initiation of nCPAP Informed Consent Exclusion Criteria: Heart rate that cannot be stabilized >100 bpm within 5 minutes of birth Five (5) minute Apgar score ≤ 3 Major congenital malformation(s) diagnosed antenatally or noted immediately after birth Other disease(s) or conditions potentially interfering with cardiopulmonary function Mother with prolonged rupture of membranes > 2 weeks Known or suspected chromosomal abnormality Need for chest compressions or administration of epinephrine, bicarbonate, or fluid boluses in the delivery room Need for mechanical ventilation within 30 minutes of birth

Ages Eligible for Study
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Minimum Age: 15 Minutes
Maximum Age: 30 Minutes

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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regimen 1<br> | Drug: Aerosolized lucinactant<br>* Aerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment separated by at least 3 hours.<br>* Other names: KL₄Surfactant;|
| Experimental: Regimen 2<br> | Drug: Aerosolized lucinactant<br>* Aerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment separated by at least 1 hour.<br>* Other names: KL₄Surfactant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Respiratory Distress Syndrome |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve (AUC) for Fraction of Inspired Oxygen (FiO₂) | AUC for FiO₂calculated using the trapezoidal rule. Missing data imputed using last observation carried forward | 0.5, 1, 2, 4, 6, 12, 18, 24, 36, 48, 60, 72 hours | 
| Arterial Alveolar (a/A) O₂Ratio | a/A ratio is a relative way to judge the lungs ability to transport O₂. It compares the partial pressure of O₂in the alveoli (A) to the partial pressure of O₂in the artery (a). It is calculated by dividing the partial pressure of O₂in the artery, abbreviated PaO2, by the partial pressure of O₂in the alveoli using the alveolar gas equation, abbreviated PAO2. A value of 0.80 or above is normal, a value of 0.60 or below may be incompatible with spontaneous breathing, and a value below 0.22 indicates severe lung disease. | 72 hours | 
| Time to Meet Failure Criteria | Failure criteria defined as rescue with bolus surfactant and mechanical ventilation | Through 28 days | 
| Number of Participants With Bronchopulmonary Dysplasia (BPD) |  | 28 days | 
| Number of Participants Alive and Without BPD |  | 28 days | 
| Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL) |  | 28 days | 
| Number of Participants With Patent Ductus Arteriosus (PDA) |  | 28 days | 
| Number of Participants With Necrotizing Enterocolitis (NEC) |  | 28 days | 
| Number of Participants With Pulmonary Hemorrhage |  | 28 days | 
| Number of Participants With Acquired Sepsis |  | 28 days | 
| Incidence of Mortality |  | 28 days | 
| Number of Participants With Air Leak |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lucinactant, Nasal continuous positive airway pressure (nCPAP), Respiratory distress syndrome (RDS), Pediatric, Premature