A Phase 3 interventional study of Pentoxifylline and Probiotic Formula in Necrotizing Enterocolitis, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged Up to 37 Weeks. Per ClinicalTrials.gov, last updated 2024-05-20.
Sponsored by Tanta University · Phase 3, Interventional, and Treatment
The aim of this study is to evaluate the effectiveness of pentoxifylline versus probiotics supplementation as adjuvant therapy for preterm neonates with necrotizing enterocolitis.
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.
228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.
This study's enrollment of 75 is below the median of 103 across 127 interventional studies indexed under Enterocolitis, Necrotizing.
Browse Enterocolitis, Necrotizing studies →Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
will include 25 preterm neonates with NEC who will receive traditional therapy of NEC including antibiotics and normal incubator care measures
will include 25 preterm neonates with NEC who will receive traditional therapy of NEC in association with IV pentoxifylline at a dose of 30 mg/kg given over 6 hours daily (Schüller et al., 2020) until discharge from the unit after clinical and laboratory improvement .
Drug: Pentoxifylline
will include 25 preterm neonates with NEC who will receive traditional therapy of NEC in association with 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 .
Drug: Probiotic Formula
Pentoxifylline 30 mg/kg given over 6 hours daily
Also known as: 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 .
Also known as: group 3 (Probiotic group)
Mortality rate
record mortality rate in each group during treatment
Time frame: 2 months
complications and side effects
record any complications or side effects of the treating drugs
Time frame: 2 months
Inflammatory parameter
Change in serum C-reactive protein at baseline and after 2 months
Time frame: 2 months
change in serum high-mobility group box protein 1 (HMGB1)
blood sample will be collected at baseline and after 2 months
Time frame: 2 months
change in serum Intestinal fatty acid binding protein (I-FABP).
blood sample will be collected at baseline and after 2 months
Time frame: 2 months
change in serum total antioxidant capacity (TAC)
Blood sample will be collected at baseline and after 2 months
Time frame: 2 months
Ran from Jun 2022 to primary completion in Nov 2023, 16 months.
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pentoxifylline