Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old (KL4-AHRF-01)
May 1, 2012 updated by: Windtree Therapeutics
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
165
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Concepcion, Chile
- Call For Information
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Santiago, Chile
- Call For Information
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Pennsylvania
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Warrington, Pennsylvania, United States, 18976
- Call For Information
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 2 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Lucinactant
SURFAXIN® (lucinactant) for intratracheal instillation
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Slow intra-tracheal instillation
Other Names:
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Sham Comparator: Sham Air
Sham air (placebo) instillation
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Slow intra-tracheal instillation
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Duration of Mechanical Ventilation Through 14 Days
Time Frame: Up to 14 Days
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Duration of mechanical ventilation (MV) from baseline to successful extubation (not receiving MV for at least 24 hours) through a maximum of 14 days.
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Up to 14 Days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days
Time Frame: Up to 14 days
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Up to 14 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Neal Thomas, MD, Milton S. Hershey Medical Center
- Principal Investigator: Adrienne Randolph, MD, Boston Children's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
December 19, 2007
First Submitted That Met QC Criteria
December 20, 2007
First Posted (Estimate)
December 21, 2007
Study Record Updates
Last Update Posted (Estimate)
May 3, 2012
Last Update Submitted That Met QC Criteria
May 1, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KL4-AHRF-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.