![]() |
|
![]() |
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsored by: |
Discovery Laboratories |
Information provided by: | Discovery Laboratories |
ClinicalTrials.gov Identifier: | NCT00215540 |
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 |
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. |
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).
Ages Eligible for Study: | up to 10 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Premature infants between 600 and 900 grams birth weight
Exclusion Criteria:
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 |
|
|
![]() |