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

Phase 2

Completed

• Conditions: Acute Hypoxemic Respiratory Failure
• Interventions: Other: Sham Comparator; Drug: Lucinactant

• Registration Number: NCT00578734
• Lead Sponsor: Windtree Therapeutics

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2007-12-21
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Results First Submitted: 2012-04-02
• Results First Submitted QC: 2012-04-02
• Results First Posted: 2012-04-27
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-01
• Last Update Posted: 2012-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Air	Sham Comparator	Sham air (placebo) instillation
Lucinactant	Lucinactant	SURFAXIN® (lucinactant) for intratracheal instillation

Primary Outcome Measures

Name	Time	Method
Duration of Mechanical Ventilation Through 14 Days	Up to 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.

Secondary Outcome Measures

Name	Time	Method
Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days	Up to 14 days

Trial Locations

Locations (3)

Call For Information; 🇨🇱 Santiago, Chile

Call for information; 🇺🇸 Warrington, Pennsylvania, United States

Call for Information; 🇨🇱 Concepcion, Chile