Tanta University
Tanta, El Gharbia, Egypt
NCT Number: NCT06422000
The aim of this study is to evaluate the effectiveness of pentoxifylline versus probiotics supplementation as adjuvant therapy for preterm neonates with necrotizing enterocolitis.
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Notify MeUp to 37 week
All sexes
Interventional
Phase 3
Tanta, El Gharbia, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pentoxifylline 30 mg/kg given over 6 hours daily
Other names: group 2 (Pentoxifylline group)
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 .
Other names: group 3 (Probiotic group)
Time frame: 2 months
record mortality rate in each group during treatment
Time frame: 2 months
record any complications or side effects of the treating drugs
Time frame: 2 months
Change in serum C-reactive protein at baseline and after 2 months
Time frame: 2 months
blood sample will be collected at baseline and after 2 months
Time frame: 2 months
blood sample will be collected at baseline and after 2 months
Time frame: 2 months
Blood sample will be collected at baseline and after 2 months
Tanta University
Other
Pentoxifylline Versus Probiotic as Adjuvant Therapy for Preterm Neonates With Necrotizing Enterocolitis
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