Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004500
Status:
TERMINATED
Last Update Posted:
2012-05-03
First Post:
1999-10-18
Brief Title:
Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
Sponsor:
Windtree Therapeutics
Organization:
Windtree Therapeutics
Study Overview
Official Title:
A Multicenter Randomized Controlled Trial Comparing the Safety and Effectiveness of Bronchoalveolar Lavage With Lucinactant to Standard Care for the Treatment of the Meconium Aspriation Syndrome MAS in Newborn Infants
Status:
TERMINATED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow enrollment and administrative reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES
Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage BAL in the treatment of meconium aspiration syndrome MAS in newborn infants
Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage BAL in the treatment of meconium aspiration syndrome MAS in newborn infants
Detailed Description:
PROTOCOL OUTLINE
This is a randomized multicenter study Patients are randomized to one of two treatment arms
Arm I Patients receive lucinactant by bronchoalveolar lavage into the right and left lung followed by lung drainage Treatment repeats when patient stabilizes or every 15 minutes for 2 courses
Arm II Patients receive standard treatment including oxygen conventional mechanical ventilation sedation paralysis vasopressors and alkalinization
Patients are followed for 12 months
This is a randomized multicenter study Patients are randomized to one of two treatment arms
Arm I Patients receive lucinactant by bronchoalveolar lavage into the right and left lung followed by lung drainage Treatment repeats when patient stabilizes or every 15 minutes for 2 courses
Arm II Patients receive standard treatment including oxygen conventional mechanical ventilation sedation paralysis vasopressors and alkalinization
Patients are followed for 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FD-R-001938 | OTHER_GRANT | US Department of Health and Human Services | None |