Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old

Study Overview
=================
Brief Summary
-----------------
Treatment with lucinactant, a peptide-containing synthetic lung surfactant, will be evaluated in young children with acute respiratory failure who require mechanical ventilation (life support), to determine if it is safe and if treatment with lucinactant will reduce the number of days a child needs mechanical ventilation (life support).

Detailed Description
-----------------
Determine the safety and tolerability of administration of a peptide-containing synthetic lung surfactant, lucinactant, in children up to two years of age and assess whether treatment with lucinactant can decrease the duration of mechanical ventilation in young children.

Official Title
-----------------
A Multicenter, Randomized, Masked, Placebo-Controlled Trial to Assess the Safety and Efficacy of Lucinactant in Acute Hypoxemic Respiratory Failure in Children Up to Two Years of Age

Conditions
-----------------
Acute Hypoxemic Respiratory Failure

Intervention / Treatment
-----------------
* Drug: Lucinactant
* Other: Sham Comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 38 weeks (corrected age) to 2 years (24 months) Intubated and mechanically ventilated (MV) for ≥ 6 hours and anticipated need for MV for ≥ 24 hours Persistent hypoxia Written informed consent Exclusion Criteria: Mechanical Ventilation for > 48 hours Oxygenation index ≥ 25, if arterial line was avialable Pre-existing clinically significant or palliated/uncorrected cardiac disease adversely affecting cardiopulmonary function and gas exchange Neuromuscular disease or hypotonia Upper airway disease Baseline requirment for supplemental oxygen Untreated pneumothorax Off-label use of commercially available surfactant outside neonatal period History of prematurity and passive immunoprophylaxis with humanized monoclonal antibody Head injury with Glasgow Coma Scale < 8 Brain death or impending brain death Do not resuscitate orders Cardiopulmonary resuscitation within 6 hours of meeting entry criteria Experimental therapy in which the intervention potentially affects respiratory outcomes Any transplant recipient Meconium aspiration syndrome Bordetella pertussis infection confirmed via laboratory tests and/or highly suspected pertussis infection

Ages Eligible for Study
-----------------
Maximum Age: 2 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lucinactant<br>SURFAXIN® (lucinactant) for intratracheal instillation | Drug: Lucinactant<br>* Slow intra-tracheal instillation<br>* Other names: Surfactant;|
| Sham Comparator: Sham Air<br>Sham air (placebo) instillation | Other: Sham Comparator<br>* Slow intra-tracheal instillation<br>* Other names: Placebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Mechanical Ventilation Through 14 Days | Duration of mechanical ventilation (MV) from baseline to successful extubation (not receiving MV for at least 24 hours) through a maximum of 14 days. | Up to 14 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days |  | Up to 14 days |