NCT06422000

Effect of Pentoxifylline Versus Probiotic on Preterm Neonates With Necrotizing Enterocolitis

Pentoxifylline Versus Probiotic as Adjuvant Therapy for Preterm Neonates With Necrotizing Enterocolitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 37 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Necrotizing Enterocolitis

Interventions

Type	Name	Description
DRUG	Pentoxifylline	Pentoxifylline 30 mg/kg given over 6 hours daily
DRUG	Probiotic Formula	probiotics sachets supplementation, in the form of lyophilized lactic acid bacteria each Aluminium stick pack contains 100 mg ( Meyer et al., 2020) Probio Tec BB12-Blend 30- IF\* (SANDOZ®.) mixed with 10 ml sterile water and given by Ryle tube once daily until discharge from the unit after clinical and laboratory improvement .

Timeline

• Start date: 2022-06-30
• Primary completion: 2023-11-01
• Completion: 2023-12-30
• First posted: 2024-05-20
• Last updated: 2024-05-20

Locations

1 site across 1 country: Egypt