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

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

ChemIDplus related topics:

Lucinactant Sinapultide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

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

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 ]

Estimated Enrollment:	172
Study Start Date:	June 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

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

Contacts


Contact: Carlos Guardia, MD	215-488-9506	cguardia@discoverylabs.com

Locations


Chile
	Call for Information	Recruiting
	Concepcion, Chile
	Call For Information	Recruiting
	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

Responsible Party:	Discovery Laboratories, Inc. ( Carlos Guardia, MD )
Study ID Numbers:	KL4-AHRF-01
First Received:	December 19, 2007
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00578734
Health Authority:	United States: Food and Drug Administration; Chile: Instituto de Salud Publica de Chile

Study placed in the following topic categories:

Respiratory Insufficiency

Respiratory Tract Diseases

Respiration Disorders

ClinicalTrials.gov processed this record on October 10, 2008

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