Effect of Pentoxifylline Versus Probiotic on Preterm Neonates With Necrotizing Enterocolitis

NCT ID: NCT06422000

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2023-12-30

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.

Conditions

Necrotizing Enterocolitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

control group (group I)

will include 25 preterm neonates with NEC who will receive traditional therapy of NEC including antibiotics and normal incubator care measures

Group Type: NO_INTERVENTION

No interventions assigned to this group

pentoxifylline group (group II)

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 .

Group Type: ACTIVE_COMPARATOR

Pentoxifylline

Intervention Type: DRUG

Pentoxifylline 30 mg/kg given over 6 hours daily

probiotic group (group III)

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 .

Group Type: ACTIVE_COMPARATOR

Probiotic Formula

Intervention Type: DRUG

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 .

Interventions

Pentoxifylline

Pentoxifylline 30 mg/kg given over 6 hours daily

Intervention Type: 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 .

Intervention Type: DRUG

Other Intervention Names

group 2 (Pentoxifylline group); group 3 (Probiotic group)

Eligibility Criteria

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

• Maximum Eligible Age: 37 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Alaa Mohamed Ahmed Rowisha

clinical pharmacist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sahar Hegazy, MD

Role: STUDY_DIRECTOR

professor and head of clinical pharmacy department, faculty of Pharmact, Tanta University, Egypt

Locations

Tanta University

Tanta, El Gharbia, Egypt

Countries

Egypt

Other Identifiers

pentoxifylline probiotic NEC

Identifier Type: -

Identifier Source: org_study_id