Trials
Search / Trial NCT06422000

Effect of Pentoxifylline Versus Probiotic on Preterm Neonates With Necrotizing Enterocolitis

Launched by TANTA UNIVERSITY · May 14, 2024

Trial Information

Current as of February 19, 2025

Completed

Keywords

ClinConnect Summary

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 wat...

Gender

ALL

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

Trial Officials

Sahar Hegazy, MD

Study Director

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

About Tanta University

Tanta University is a prestigious academic institution located in Egypt, dedicated to advancing medical research and education. As a clinical trial sponsor, Tanta University leverages its extensive resources and expertise to conduct innovative research initiatives aimed at improving health outcomes. The university collaborates with a network of healthcare professionals, researchers, and institutions to facilitate rigorous clinical trials across various medical disciplines. Committed to ethical standards and scientific integrity, Tanta University strives to contribute to the global body of knowledge while fostering the next generation of medical professionals.

Locations

Tanta, El Gharbia, Egypt

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0