Cohort Isolation and Cross-infection in Bronchiolitis

This study has been completed.
Information provided by (Responsible Party):
Jolita Bekhof, Princess Amalia Children's Clinic Identifier:
First received: September 23, 2011
Last updated: October 8, 2012
Last verified: October 2012

The purpose of this study is to investigate the effect of cohort isolation of RS(respiratory syncytial virus)-positive bronchiolitis versus RS-negative bronchiolitis on prevention of co-infection and clinical disease severity. Furthermore the investigators want to elucidate general epidemiological data on bronchiolitis concerning viral causes and the associated clinical severity.

The investigators want to conduct a prospective cohort study, comparing incidence of co-infection and clinical severity, in two cohort: one with isolation of RS positive bronchiolitis as a separate cohort within bronchiolitis and one without isolation (all children with RS-negative bronchiolitis are nursed together independent of viral agent)

Condition Intervention
Other: Isolation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cross-infection in Children Hospitalized for Bronchiolitis: Incidence, Symptoms en Effect of Cohort Isolation

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Duration of hospital stay [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • severity of disease [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    duration of tube feeding, duration of supplemental oxygen, need for mechanical ventilation, dyspnoea score

Biospecimen Retention:   Samples Without DNA


Enrollment: 48
Study Start Date: November 2011
Study Completion Date: May 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group without isolation
Patients in this arm are nursed together (in the same room) independent of viral agent.
Other: Isolation
Patients in this arm are nursed together (in the same room) independent of viral agent
group with isolation
Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients


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

Infants admiittted for bronchiolitis under 2 years of age


Inclusion Criteria:

  • patients under 2 years of age
  • hospitalized for bronchiolitis

Exclusion Criteria:

  • bronchopulmonary disease
  • congenital heart defect,
  • congenital pulmonary disease,
  • Down's syndrome
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Please refer to this study by its identifier: NCT01441466

Isala Klinieken
Zwolle, Netherlands, 8000GK
Sponsors and Collaborators
Princess Amalia Children's Clinic
Principal Investigator: Jolita Bekhof, MD Isala
  More Information

No publications provided

Responsible Party: Jolita Bekhof, MD, Pediatrician, Princess Amalia Children's Clinic Identifier: NCT01441466     History of Changes
Other Study ID Numbers: bronchiolitis
Study First Received: September 23, 2011
Last Updated: October 8, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Princess Amalia Children's Clinic:

Additional relevant MeSH terms:
Cross Infection
Bronchial Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections processed this record on July 01, 2015