Effect of Pentoxifylline Versus Probiotic on Preterm Neonates With Necrotizing Enterocolitis

NCT06422000 | Completed Phase 3

• 1 other identifier: pentoxifylline probiotic NEC
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Necrotizing Enterocolitis

Outcome Measures

Primary Outcomes (3)

• Mortality rate

  record mortality rate in each group during treatment

  2 months

• complications and side effects

  record any complications or side effects of the treating drugs

  2 months

• Inflammatory parameter

  Change in serum C-reactive protein at baseline and after 2 months

  2 months

Secondary Outcomes (3)

• change in serum high-mobility group box protein 1 (HMGB1)

  2 months

• change in serum Intestinal fatty acid binding protein (I-FABP).

  2 months

• change in serum total antioxidant capacity (TAC)

  2 months

Study Arms (3)

control group (group I)

NO INTERVENTION

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

pentoxifylline group (group II)

ACTIVE COMPARATOR

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

probiotic group (group III)

ACTIVE COMPARATOR

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

Interventions

Pentoxifylline DRUG

Pentoxifylline 30 mg/kg given over 6 hours daily

Also known as: group 2 (Pentoxifylline group)

pentoxifylline group (group II)

Probiotic Formula 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 .

Also known as: group 3 (Probiotic group)

probiotic group (group III)

Eligibility Criteria

• Age: Up to 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Term and post term neonates
• Neonates with congenital infections
• Neonates with major congenital anomalies
• Neonates with stage III NEC

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El Gharbia, Egypt

Location

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sahar Hegazy, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical pharmacist

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: May 20, 2024
• Study Start: June 30, 2022
• Primary Completion: November 1, 2023
• Study Completion: December 30, 2023
• Last Updated: May 20, 2024

Record last verified: 2024-05

Locations

EG (1)