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

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ClinicalTrials.gov Identifier: NCT00578734
Recruitment Status : Completed
First Posted : December 21, 2007
Results First Posted : April 27, 2012
Last Update Posted : May 3, 2012
Sponsor:
Information provided by (Responsible Party):
Windtree Therapeutics

Study Description
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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).

Condition or disease Intervention/treatment Phase
Acute Hypoxemic Respiratory Failure Drug: Lucinactant Other: Sham Comparator Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : June 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Duration of Mechanical Ventilation Through 14 Days [ Time Frame: Up to 14 Days ]
    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 :
  1. Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days [ Time Frame: Up to 14 days ]

Eligibility Criteria
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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00578734


Locations
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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
Windtree Therapeutics
Investigators
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Principal Investigator: Neal Thomas, MD Milton S. Hershey Medical Center
Principal Investigator: Adrienne Randolph, MD Boston Children's Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Windtree Therapeutics
ClinicalTrials.gov Identifier: NCT00578734    
Other Study ID Numbers: KL4-AHRF-01
First Posted: December 21, 2007    Key Record Dates
Results First Posted: April 27, 2012
Last Update Posted: May 3, 2012
Last Verified: May 2012
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Pulmonary Surfactants
Respiratory System Agents