Surfaxin Treatment for Prevention of Bronchopulmonary Dysplasia in Very Low Birth Weight (VLBW) Infants. - Full Text View

Purpose

Surfaxin treatment will be examined in very low birth weight infants to prevent development of chronic lung disease, commonly known as BPD, in premature infants who have required continued intubation and received surfactants for the prevention or treatment of Respiratory Distress Syndrome (RDS).

Condition	Intervention	Phase
Respiratory Distress Syndrome, Newborn Premature Birth Bronchopulmonary Dysplasia	Drug: Surfaxin (Drug) (low dose, high dose); Slow intra-tracheal instillation of Surfaxin or sham air (Procedure)	Phase II

Drug Information available for:

Lucinactant Sinapultide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Efficacy of Surfaxin® (Lucinactant), in Very Low Birth Weight (VLBW) Infants at Risk for Developing Bronchopulmonary Dysplasia.

Further study details as provided by Discovery Laboratories:

Primary Outcome Measures:

• Safety
• Efficacy
o Proportion of infants remaining on mechanical ventilation or oxygen over time
o Incidence of death or BPD at 28 days and 36 weeks PMA
o AUC day 3-28 FiO2 and MAP between treatment groups

Secondary Outcome Measures:

All-cause mortality

Detailed Description:

Determine the safety and tolerability of Surfaxin administration in the first weeks of life as a therapeutic approach for prevention of BPD. Determine whether treatment with Surfaxin during the first two to three weeks of life can decrease the proportion of infants on mechanical ventilation or oxygen or the incidence of death or BPD in VLBW infants when assessed at 28 days of life and 36 weeks post-menstrual age (as determined by the need for supplemental oxygen).

Eligibility

Ages Eligible for Study:	up to 10 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Premature infants between 600 and 900 grams birth weight

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00215540

Locations


United States, Pennsylvania
	Discovery Laboratories, Inc.
	Warrington, Pennsylvania, United States, 18976-3646

Sponsors and Collaborators

Discovery Laboratories

More Information

Study ID Numbers:	KL4-BPD-01
First Received:	September 14, 2005
Last Updated:	December 4, 2007
ClinicalTrials.gov Identifier:	NCT00215540
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Bronchopulmonary dysplasia

Birth Weight

Pregnancy Complications

Obstetric Labor, Premature

Respiration Disorders

Respiratory Distress Syndrome, Newborn

Obstetric Labor Complications

Infant, Premature, Diseases

Bronchopulmonary Dysplasia

Body Weight

Signs and Symptoms

Respiratory Tract Diseases

Lung Diseases

Infant, Newborn, Diseases

Premature Birth

ClinicalTrials.gov processed this record on November 04, 2008

Sponsored by:	Discovery Laboratories
Information provided by:	Discovery Laboratories
ClinicalTrials.gov Identifier:	NCT00215540