Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00271336
Status:
UNKNOWN
Last Update Posted:
2008-05-23
First Post:
2005-12-29
Brief Title:
Pentoxifylline in the Treatment of NEC in Premature Neonates
Sponsor:
Shaare Zedek Medical Center
Organization:
Shaare Zedek Medical Center
Study Overview
Official Title:
Pentoxifylline in the Treatment of Necrotizing Enterocolitis in Premature Neonates
Status:
UNKNOWN
Status Verified Date:
2005-12
Last Known Status:
RECRUITING
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:
Pentoxifylline improves microcirculation and decreases TNF alpha levels associated with sepsis rendering it of potential therapeutic value in necrotizing enterocolitis in premature neonates
Detailed Description:
Preterm neonates with a clinical suspicion of necrotizing enterocolitis NEC will potentially be candidates for study After obtaining parental consent the infants will be prospectively and randomly assigned to one of two groups 1 Treatment group to receive IV pentoxifylline 5 mgkghour to run over 6 hour x 6 days and 2 Placebo group to receive an equal volume of ½ normal saline to run over 6 hours x 6 days
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