Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422000
Status:
COMPLETED
Last Update Posted:
2024-05-20
First Post:
2022-11-11
Brief Title:
Effect of Pentoxifylline Versus Probiotic on Preterm Neonates With Necrotizing Enterocolitis
Sponsor:
Tanta University
Organization:
Tanta University
Study Overview
Official Title:
Pentoxifylline Versus Probiotic as Adjuvant Therapy for Preterm Neonates With Necrotizing Enterocolitis
Status:
COMPLETED
Status Verified Date:
2024-05
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 aim of this study is to evaluate the effectiveness of pentoxifylline versus probiotics supplementation as adjuvant therapy for preterm neonates with necrotizing enterocolitis
Detailed Description:
This randomized clinical trial includes 75 preterm infants who met the inclusion criteria for stage I and stage II NEC Patients are allocated randomly into three groups each included 25 neonates group I traditional therapy group received antibiotics according to culture and sensitivity results group II pentoxifylline group received antibiotics and IV pentoxifylline at a dose of 30 mg Kg given over 6 hours daily until discharge from the unit and group III probiotics group received antibiotics and probiotics sachets supplementation in a dose of 100 mg mixed with 10 ml sterile water and given by Ryle tube once daily until discharge The serum level of high-mobility group box protein 1 HMGB-1 intestinal fatty acid binding proteins I-FABP and total antioxidant capacity TAC were measured on admission and at discharge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None