Co-infections in Children Hospitalised for Bronchiolitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Princess Amalia Children's Clinic
Sponsor:
Information provided by (Responsible Party):
Jolita Bekhof, Princess Amalia Children's Clinic
ClinicalTrials.gov Identifier:
NCT01714076
First received: October 8, 2012
Last updated: October 22, 2013
Last verified: October 2013
  Purpose

Observational cohort study in children hospitalized for acute bronchiolitis. Patients are nursed in cohort isolation. Aim is to investigate the incidence and clinical impact of co-infections in this group.


Condition Intervention
Bronchiolitis
Other: cohort isolation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Co-infections in Children Hospitalised for Bronchiolitis: Incidence, Clinical Symptoms and Influence of Cohort Isolation

Resource links provided by NLM:


Further study details as provided by Princess Amalia Children's Clinic:

Primary Outcome Measures:
  • co-infection [ Time Frame: approximately 2 weeks ] [ Designated as safety issue: Yes ]
    co-infection acquired during hospitalisation, patient will be followed during hospitalisation and until 1 week after discharge from the hospital, since average duration of hospitalisation in infants with bronchiolitis is 3 days, the time frame will be approximately 2 weeks


Secondary Outcome Measures:
  • clinical severity [ Time Frame: approximately 2 weeks ] [ Designated as safety issue: No ]
    clinical severity defined as, days of oxygen supplementation, tube feeding, dyspnea score, length of hospitalisation


Biospecimen Retention:   Samples Without DNA

sputum tested for viral agents by PCR-techniques


Estimated Enrollment: 80
Study Start Date: November 2012
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
cohort isolation
patients with bronchiolitis are cohorted together irrespective of viral agent diagnosed, thus respiratory syncytial virus (RSV)-positive patient stay in the same room as RSV-negative patients
Other: cohort isolation
all patients hospitalised for bronchiolitis are nursed in one room together, separated from patients without bronchiolitis

Detailed Description:

Observational cohort study in children hospitalized for acute bronchiolitis. Patients are nursed in cohort isolation, meaning that all patients admitted for bronchiolitis are cohorted together, irrespective of viral diagnosis. Aim is to investigate the incidence and clinical impact of co-infections in this group.

  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

children < 2 years admitted for bronchiolitis

Criteria

Inclusion Criteria:

  • younger than 2 years admitted for bronchiolitis

Exclusion Criteria:

  • chronic lung disease congenital heart defect down syndrome
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714076

Contacts
Contact: Jolita Bekhof, MD +31384245050 j.bekhof@isala.nl

Locations
Netherlands
Isala Klinieken Recruiting
Zwolle, Overijssel, Netherlands, 8000 GK
Contact: Jolita Bekhof, MD    ++31384245050    j.bekhof@isala.nl   
Principal Investigator: Jolita Bekhof, MD         
Sponsors and Collaborators
Princess Amalia Children's Clinic
Investigators
Principal Investigator: Jolita Bekhof, MD Isala Klinieken
  More Information

No publications provided

Responsible Party: Jolita Bekhof, MD, Princess Amalia Children's Clinic
ClinicalTrials.gov Identifier: NCT01714076     History of Changes
Other Study ID Numbers: JB-3
Study First Received: October 8, 2012
Last Updated: October 22, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Bronchiolitis
Coinfection
Bronchial Diseases
Bronchitis
Infection
Lung Diseases
Lung Diseases, Obstructive
Parasitic Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014