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Completed

NCT Number: NCT06422000

Effect of Pentoxifylline Versus Probiotic on Preterm Neonates With Necrotizing Enterocolitis

The aim of this study is to evaluate the effectiveness of pentoxifylline versus probiotics supplementation as adjuvant therapy for preterm neonates with necrotizing enterocolitis.

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Key information

Age range

Up to 37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tanta University

Tanta, El Gharbia, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pentoxifylline

Drug

Pentoxifylline 30 mg/kg given over 6 hours daily

Other names: group 2 (Pentoxifylline group)

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 .

Other names: group 3 (Probiotic group)

Primary outcomes

  1. Mortality rate

    Time frame: 2 months

    record mortality rate in each group during treatment

  2. complications and side effects

    Time frame: 2 months

    record any complications or side effects of the treating drugs

  3. Inflammatory parameter

    Time frame: 2 months

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

Secondary outcomes

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

    Time frame: 2 months

    blood sample will be collected at baseline and after 2 months

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

    Time frame: 2 months

    blood sample will be collected at baseline and after 2 months

  3. change in serum total antioxidant capacity (TAC)

    Time frame: 2 months

    Blood sample will be collected at baseline and after 2 months

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 20, 2024
Registry last updated
May 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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