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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
ClinicalTrials.gov Identifier:
NCT00578734
First received: December 19, 2007
Last updated: May 1, 2012
Last verified: May 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Acute Hypoxemic Respiratory Failure
 Drug: Lucinactant
Other: Sham Comparator
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Discovery Laboratories:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 165
Study Start Date: June 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lucinactant
SURFAXIN® (lucinactant) for intratracheal instillation
 Drug: Lucinactant
Slow intra-tracheal instillation
Other Names:
  • SURFAXIN®
  • Surfactant
Sham Comparator: Sham Air
Sham air (placebo) instillation
 Other: Sham Comparator
Slow intra-tracheal instillation
Other Name: Placebo

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

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00578734

Locations
United States, Pennsylvania
Call for information
Warrington, Pennsylvania, United States, 18976
Chile
Call for Information
Concepcion, Chile
Call For Information
Santiago, Chile
Sponsors and Collaborators
Discovery Laboratories
Investigators
Principal Investigator: Neal Thomas, MD Milton S. Hershey Medical Center
Principal Investigator: Adrienne Randolph, MD Children's Hospital Boston
  More Information

No publications provided by Discovery Laboratories

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Discovery Laboratories
ClinicalTrials.gov Identifier: NCT00578734     History of Changes
Other Study ID Numbers: KL4-AHRF-01
Study First Received: December 19, 2007
Results First Received: April 2, 2012
Last Updated: May 1, 2012
Health Authority: United States: Food and Drug Administration
Chile: Instituto de Salud Publica de Chile

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013