Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165074
Status:
COMPLETED
Last Update Posted:
2007-11-22
First Post:
2005-09-09
Brief Title:
Pilot Trial of Surfactant Therapy For Preterm Neonates 5-21 Days Old With Respiratory Decompensation
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
Pilot Trial of Surfactant Therapy For Preterm Neonates 5-21 Days Old With
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to determine whether additional surfactantInfasurf doses at 7 to 10 days of life time will improve lung function in premature infants allowing a decrease in required oxygen concentration and ventilator settings
Detailed Description:
Pulmonary surfactant is required for normal lung function Preliminary data from previous trials suggest that more than half of chronically ventilated premature infants greater than 1 week of age have at least one episode of surfactant dysfunction as measured in vitro associated with a low surfactant protein B content We propose to enroll premature infants less than 1250 gm birthweight between days 5 and 21 of life who are intubated mechanically ventilated with a respiratory decompensation defined as a severity score mean airway pressure x FIO2 rising from a baseline of 18 to 35 sustained for 24 hours Infants will receive two doses of Infasurf surfactant 12-24 hours apart at the standard dose of 3 mlkg Primary outcome is the change in respiratory severity score at 72 hours post surfactant treatment compared to pre-treatment Sample size is 31 infants study duration is 3 years and recruitment of study patients will occur at the Hospital of the University of Pennsylvania and Women and Childrens Hospital of Buffalo
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