Viral Respiratory and Gastrointestinal Infections in Children Under 6 Years of Age

Viral Respiratory and Gastrointestinal Infections in Children Under 6 Years of Age - the Clinical Relevance of Newly Discovered Viruses

With the use of molecular methods new viruses have been detected in respiratory and gastrointestinal tracts of both patients and asymptomatic subjects in recent years. The clinical importance of these viruses has not been adequately studied.

The aim of this study is to use molecular methods to detect viruses in upper respiratory tract and gastrointestinal tract of children with acute bronchiolitis, acute gastroenteritis and febrile convulsions and to try to correlate the severity of clinical picture with the amount of viruses present in clinical samples. The investigators will also try to detect the increase in specific antibodies in paired sera.

Study Overview

• Status: Unknown
• Conditions: Gastroenteritis; Bronchiolitis; Convulsion, Febrile

• Study Type: Observational
• Enrollment (Anticipated): 1260

Contacts and Locations

• Study Contact: Name: Marko Pokorn, MD, MSc; Phone Number: +38641712241; Email: marko.pokorn@mf.uni-lj.si
• Study Contact Backup: Name: Tatjana Mrvič, MD, MSc; Phone Number: +38615222110; Email: tatjana.mrvic@guest.arnes.si

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • Department of Infectious Diseases, University Medical Centre Ljubljana
    • Contact: Marko Pokorn, MD; Phone Number: +38641712241; Email: marko.pokorn@mf.uni-lj.si
    • Contact: Tatjana Mrvič, MD; Phone Number: +38615222110; Email: tatjana.mrvic@guest.arnes.si
    • Sub-Investigator: Tatjana Mrvič, MD, MSc
    • Principal Investigator: Marko Pokorn, MD, MSc
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • Department of Pediatric Surgery, University Medical Centre Ljubljana
    • Contact: Štefan Grosek, MD, PhD; Phone Number: +38615228137; Email: stefan.grosek@guest.arnes.si
    • Principal Investigator: Štefan Grosek, MD, PhD
  • Ljubljana, Slovenia, 1000
    • Not yet recruiting
    • Institute of microbiology and immunology
    • Contact: Miroslav Petrovec, MD, PhD; Phone Number: +38615437452; Email: mirc.petrovec@mf.uni-lj.si
    • Contact: Monika Jevšnik, BSc; Phone Number: +38615437452; Email: moni.jevsnik@gmail.com
    • Principal Investigator: Miroslav Petrovec, MD, PhD
    • Sub-Investigator: Monika Jevšnik, BSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children under 6 years of age admitted to Department of Infectious Diseases, University Medical Centre Ljubljana with a diagnosis of acute bronchiolitis, acute gastroenteritis or febrile convulsion.

Description

Inclusion Criteria:

presence of

• acute bronchiolitis
• acute gastroenteritis
• febrile convulsion requiring hospital admission

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Acute bronchiolitis; Patients with acute bronchiolitis - the presence of nasal discharge, cough, wheezing and/or crackles on lung auscultation.
Acute gastroenteritis; Patients with 3 or more loose or liquid stools in 24 hours prior to entering the study.
Febrile convulsion; Patients with a cerebral paroxysm accompanied by fever without signs of central nervous system infection.
Control group; Patients referred to pediatric surgery for elective surgical procedure - judged to be free of clinical signs and symptoms of infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To describe the clinical picture of a viral respiratory and/or gastrointestinal infection associated with a specific viral pathogen	In a 14-day period

Secondary Outcome Measures

Outcome Measure	Time Frame
To correlate the severity of clinical picture with the quantity of virus in clinical samples	In a 14-day period

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Collaborators: University of Ljubljana School of Medicine, Slovenia
• Investigators: Principal Investigator: Marko Pokorn, MD, MSc, Department of Infectious Diseases, University Medical Centre Ljubljana; Study Chair: Franc Strle, MD, PhD, Department of Infectious Diseases, University Medical Centre Ljubljana; Principal Investigator: Miroslav Petrovec, MD, PhD, Institute of microbiology and immunology

Publications and helpful links

General Publications

• Pokorn M, Jevsnik M, Petrovec M, Steyer A, Mrvic T, Grosek S, Lusa L, Strle F. Respiratory and Enteric Virus Detection in Children. J Child Neurol. 2017 Jan;32(1):84-93. doi: 10.1177/0883073816670820. Epub 2016 Oct 3.
• Jevsnik M, Steyer A, Pokorn M, Mrvic T, Grosek S, Strle F, Lusa L, Petrovec M. The Role of Human Coronaviruses in Children Hospitalized for Acute Bronchiolitis, Acute Gastroenteritis, and Febrile Seizures: A 2-Year Prospective Study. PLoS One. 2016 May 12;11(5):e0155555. doi: 10.1371/journal.pone.0155555. eCollection 2016.
• Jevsnik M, Steyer A, Zrim T, Pokorn M, Mrvic T, Grosek S, Strle F, Lusa L, Petrovec M. Detection of human coronaviruses in simultaneously collected stool samples and nasopharyngeal swabs from hospitalized children with acute gastroenteritis. Virol J. 2013 Feb 5;10:46. doi: 10.1186/1743-422X-10-46.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Anticipated): October 1, 2010
• Study Completion (Anticipated): October 1, 2010

Study Registration Dates

• First Submitted: September 30, 2009
• First Submitted That Met QC Criteria: September 30, 2009
• First Posted (Estimate): October 1, 2009

Study Record Updates

• Last Update Posted (Estimate): July 7, 2010
• Last Update Submitted That Met QC Criteria: July 6, 2010
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: acute gastroenteritis; molecular methods; acute bronchiolitis; febrile convulsion; viral agents
• Additional Relevant MeSH Terms: Digestive System Diseases; Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Seizures; Gastroenteritis; Bronchiolitis; Seizures, Febrile
• Other Study ID Numbers: VODP