Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208039
Status:
COMPLETED
Last Update Posted:
2007-11-22
First Post:
2005-09-13
Brief Title:
Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates Less Than or Equal to 1250 gm Birthweight Ver 40
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:
A research study that will evaluate if giving surfactant medication to premature babies weighing 1250 gm at birth during the second and third weeks of life will help their lungs We are enrolling those premature babies who continue to require the breathing tube and the mechanical ventilator at days 7-10 of life
Detailed Description:
Pulmonary surfactant is required for normal lung function Data from a previous study suggest that as many as 75 of chronically ventilated extremely low birthweight premature infants have at least one episode of surfactant dysfunction beyond the first week of life as measured in vitro associated with a low surfactant protein B content Furthermore episodes of surfactant dysfunction are significantly associated with clinically significant respiratory decompensations We hypothesize that booster doses of surfactant given during the second and third week of life to extremely low birth weight premature infants requiring persistent intubation and mechanical ventilation will improve their respiratory status during the first 28 days of life We propose to enroll premature infants 1250 gm birthweight between days 7 and 10 of life who are intubated and mechanically ventilated Infants requiring persistent intubation and mechanical ventilation for respiratory support at 7-10 days of life will receive a total of 3 doses of Infasurf surfactant 3 days apart at the standard dose of 3 mlkg Primary outcome is the change in area under the respiratory severity score curve between days 7 and 28 of life Total sample size is 88 infants study duration is 36 months and recruitment of study patients will occur at The Hospital of the University of Pennsylvania in Philadelphia PA Women and Childrens Hospital in Buffalo St Louis Childrens Hospital in St Louis MO Mercy Childrens Hospital in Kansas City Oakland Childrens and Alta Bates Medical Center in Berkeley CA and Long Island Jewish Medical Center NY
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