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Actively Recruiting

Age: 1Year - 6Years
All Genders
ID07066540

Observational Study of Reamberin4 Infusion Therapy for Viral Enteric Infection in Children Aged 1 to 6 Years

Led by POLYSAN Scientific & Technological Pharmaceutical Company · Updated on 2025-07-15

300

Participants Needed

8

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate the safety and effectiveness of Reamberin solution for infusion, 1.5%, as a treatment for viral enteric infections in children aged 1 to 6 years. The study focuses on children of both sexes who have been diagnosed with viral intestinal infections and show clinical signs of intoxication. The goal is to assess the use of this drug in routine clinical practice for pathogenetic therapy. Participants receive either Reamberin at a daily dose of 10 mLkg combined with normal saline or glucose solutions, or standard infusion therapy such as normal saline, Ringers solution, or glucose solutions alone. The study is observational and open, with treatment decisions made by physicians, and it monitors the patients during the course of infusion therapy. Children enrolled in the study will be closely monitored for various health outcomes including the duration of infusion therapy, symptoms related to gastrointestinal tract damage, intoxication, fever, and hospital stay length. Assessments will be made at 24 and 48 hours after treatment begins and on day 10 to evaluate therapy continuation, symptom dynamics, electrolyte balance, dehydration severity, and blood parameters. The total study participation spans these key timepoints to track the therapys impact and safety.

CONDITIONS

Brief Title

Trial of the Efficacy and Safety of Use of Drug Product Reamberin® for Pathogenetic Therapy of Viral Enteric Infection in Children Aged 1-6 Years Old

Research Team

A

Alexey Kovalenko, Doc Biol Sci

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