Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old
Completed · Phase 2 · Has a placebo group
Conditions studied: Acute Hypoxemic Respiratory Failure
In brief
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).
Key facts
- Study ID
- NCT00578734
- Run by
- Windtree Therapeutics
- People needed
- 165
- Starts
- 2007-06-01
- Expected to finish
- 2010-04-01
- Last updated by the study team
- 2012-05-03
Who can join
Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 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
You may not qualify if…
- 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
Where it is running
- Call for information — Warrington, Pennsylvania, United States
- Call for Information — Concepción, Chile
- Call For Information — Santiago, Chile
Full record on ClinicalTrials.gov
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