Effect of Pentoxifylline Versus Probiotic on Preterm Neonates With Necrotizing Enterocolitis

Phase 3CompletedNCT06422000

Tanta University75 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Necrotizing Enterocolitis

Interventions

PentoxifyllineDRUG

Pentoxifylline 30 mg/kg given over 6 hours daily

Probiotic FormulaDRUG

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 .

Eligibility

Sex: ALLMax age: 37 Weeks

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female preterm neonates less than 37 weeks gestational age * Suffering from necrotizing enterocolitis (NEC), according to Modified Bell's system which was first proposed by Bell et al., 1978 as stage I (suspected), II (proven) . * Diagnosis of NEC depends on; history, physical examination, laboratory and radiographic findings . * Signs and symptoms of NEC (at least three or more ), including; unstable temperature, apnea, increased residual milk in stomach, mid abdominal distension, vomiting coffee-like substances, bloody stool * Laboratory findings including; thrombocytopenia, hypernatremia, metabolic acidosis, neutropenia and leukocytosis. * Anterior posterior abdominal radiograph is used for diagnosis in which pneomatosis intestinalis in stage II NEC Exclusion Criteria: * Term and post term neonates * Neonates with congenital infections * Neonates with major congenital anomalies * Neonates with stage III NEC

Locations (1)

Tanta University

Tanta, El Gharbia, Egypt

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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