Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old (KL4-AHRF-01)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Discovery Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00578734
First received: December 19, 2007
Last updated: May 1, 2012
Last verified: May 2012

December 19, 2007
May 1, 2012
June 2007
April 2010   (final data collection date for primary outcome measure)
Duration of Mechanical Ventilation Through 14 Days [ Time Frame: Up to 14 Days ] [ Designated as safety issue: No ]
Duration of mechanical ventilation (MV) from baseline to successful extubation (not receiving MV for at least 24 hours) through a maximum of 14 days.
Safety • Efficacy • Duration of mechanical ventilation through 14 days [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00578734 on ClinicalTrials.gov Archive Site
Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days [ Time Frame: Up to 14 days ] [ Designated as safety issue: No ]
Ventilator-free days • Oxygenation measurements through 48 hours after treatment • Duration of days on oxygen, ICU stay and hospitalization through 14 days [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old
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

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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Hypoxemic Respiratory Failure
  • Drug: Lucinactant
    Slow intra-tracheal instillation
    Other Names:
    • SURFAXIN®
    • Surfactant
  • Other: Sham Comparator
    Slow intra-tracheal instillation
    Other Name: Placebo
  • Experimental: Lucinactant
    SURFAXIN® (lucinactant) for intratracheal instillation
    Intervention: Drug: Lucinactant
  • Sham Comparator: Sham Air
    Sham air (placebo) instillation
    Intervention: Other: Sham Comparator
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
165
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
up to 2 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Chile
 
NCT00578734
KL4-AHRF-01
Yes
Discovery Laboratories, Inc.
Discovery Laboratories, Inc.
Not Provided
Principal Investigator: Neal Thomas, MD Milton S. Hershey Medical Center
Principal Investigator: Adrienne Randolph, MD Children's Hospital Boston
Discovery Laboratories, Inc.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP