Effect of Pentoxifylline Versus Probiotic on Preterm Neonates With Necrotizing Enterocolitis

Necrotizing Enterocolitis Clinical Trial

Official title:

Pentoxifylline Versus Probiotic as Adjuvant Therapy for Preterm Neonates With Necrotizing Enterocolitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06422000
• Other study ID #: pentoxifylline probiotic NEC
• Status: Completed
• Phase: Phase 3
• Start date: June 30, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2024
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 30, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 37 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis

Intervention

Drug:
• Pentoxifylline
Pentoxifylline 30 mg/kg given over 6 hours daily
• 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 .

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate	record mortality rate in each group during treatment	2 months
Primary	complications and side effects	record any complications or side effects of the treating drugs	2 months
Primary	Inflammatory parameter	Change in serum C-reactive protein at baseline and after 2 months	2 months
Secondary	change in serum high-mobility group box protein 1 (HMGB1)	blood sample will be collected at baseline and after 2 months	2 months
Secondary	change in serum Intestinal fatty acid binding protein (I-FABP).	blood sample will be collected at baseline and after 2 months	2 months
Secondary	change in serum total antioxidant capacity (TAC)	Blood sample will be collected at baseline and after 2 months	2 months