Phase 2
Completed N=165
Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old
Acute Hypoxemic Respiratory Failure
Source: ClinicalTrials.gov NCT00578734 ↗
Enrolled (actual)
165
Serious AEs
20.6%
Results posted
Apr 2012
Primary outcomePrimary: Duration of Mechanical Ventilation Through 14 Days — 4.0; 4.5 days
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Mechanical Ventilation Through 14 Days |
4.0; 4.5 | — |
| SECONDARY Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days |
5.2; 4.6; 6.2; 6.7; 7.7; 7.9 | — |
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
Data sourced from ClinicalTrials.gov (NCT00578734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.