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

NCT00987519 | Unknown

• 1 other identifier: VODP
• Study Type: observational
• Target: 1,260
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Bronchiolitis; Gastroenteritis; Convulsion, Febrile

Keywords

acute bronchiolitis; acute gastroenteritis; febrile convulsion; viral agents; molecular methods

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To correlate the severity of clinical picture with the quantity of virus in clinical samples

  In a 14-day period

Study Arms (4)

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.

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• University of Ljubljana School of Medicine, Slovenia: collaborator

Study Sites (3)

Department of Infectious Diseases, University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

Department of Pediatric Surgery, University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

Institute of Microbiology and Immunology

Ljubljana, 1000, Slovenia

NOT YET RECRUITING

Related Publications (3)

• 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.

  PMID: 27698149 DERIVED

• 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.

  PMID: 27171141 DERIVED

• 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.

  PMID: 23379823 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, stool and nasopharyngeal swab samples.

MeSH Terms

Conditions

Bronchiolitis; Gastroenteritis; Seizures, Febrile

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Gastrointestinal Diseases; Digestive System Diseases; Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marko Pokorn, MD, MSc

  Department of Infectious Diseases, University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

• Franc Strle, MD, PhD

  Department of Infectious Diseases, University Medical Centre Ljubljana

  STUDY CHAIR

• Miroslav Petrovec, MD, PhD

  Institute of Microbiology and Immunology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marko Pokorn, MD, MSc

CONTACT

+38641712241; marko.pokorn@mf.uni-lj.si

Tatjana Mrvič, MD, MSc

CONTACT

+38615222110; tatjana.mrvic@guest.arnes.si

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 30, 2009
• First Posted: October 1, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: July 7, 2010

Record last verified: 2009-10

Locations

SL (3)