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Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old

NCT00578734 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2012-05-03

Study results available
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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).

Conditions

  • Acute Hypoxemic Respiratory Failure

Interventions

DRUG

Lucinactant

Slow intra-tracheal instillation

OTHER

Sham Comparator

Slow intra-tracheal instillation

Sponsors & Collaborators

  • Windtree Therapeutics

    lead INDUSTRY

Principal Investigators

  • Neal Thomas, MD · Milton S. Hershey Medical Center

  • Adrienne Randolph, MD · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States
  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00578734 on ClinicalTrials.gov