Clinical trial NCT00578734: Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Hypoxemic Respiratory Failure
Lead sponsor: Windtree Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-12-21
Enrollment: 165
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Duration of Mechanical Ventilation Through 14 Days
timeFrame: Up to 14 Days
Secondary outcomes:
measure: Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days
timeFrame: Up to 14 days
Other outcomes:
Locations:
city: Warrington
country: United States
facility: Call for information
state: Pennsylvania
city: Concepcion
country: Chile
facility: Call for Information
city: Santiago
country: Chile
facility: Call For Information
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Neal Thomas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Children's Hospital
name: Adrienne Randolph, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thomas NJ, Guardia CG, Moya FR, Cheifetz IM, Markovitz B, Cruces P, Barton P, Segal R, Simmons P, Randolph AG; PALISI Network. A pilot, randomized, controlled clinical trial of lucinactant, a peptide-containing synthetic surfactant, in infants with acute hypoxemic respiratory failure. Pediatr Crit Care Med. 2012 Nov;13(6):646-53. doi: 10.1097/PCC.0b013e3182517bec.