Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old - Full Text View

Sponsor:	Discovery Laboratories
Information provided by:	Discovery Laboratories
ClinicalTrials.gov Identifier:	NCT00578734

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 II

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:

Drug Information available for: Sinapultide Lucinactant

U.S. FDA Resources

Further study details as provided by Discovery Laboratories:

Primary Outcome Measures:

Safety • Efficacy • Duration of mechanical ventilation through 14 days [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	165
Study Start Date:	June 2007
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 lucinactant	Drug: lucinactant Slow intra-tracheal instillation
Sham Comparator: 2 air	Other: Sham Comparator Slow intra-tracheal instillation

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578734

Locations

United States, Pennsylvania
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Philadelphia, Pennsylvania, United States
Chile
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Concepcion, Chile
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Santiago, Chile

Sponsors and Collaborators

Discovery Laboratories

Investigators

Principal Investigator:	Neal Thomas, MD	Penn State Children's Hospital
Principal Investigator:	Adrienne Randolph, MD	Children's Hospital Boston

More Information

No publications provided

Responsible Party:	Carlos Guardia, MD, Discovery Laboratories, Inc.
ClinicalTrials.gov Identifier:	NCT00578734 History of Changes
Other Study ID Numbers:	KL4-AHRF-01
Study First Received:	December 19, 2007
Last Updated:	June 23, 2010
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 February 09, 2012