Cohort Isolation and Cross-infection in Bronchiolitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jolita Bekhof, Princess Amalia Children's Clinic
ClinicalTrials.gov Identifier:
NCT01441466
First received: September 23, 2011
Last updated: October 8, 2012
Last verified: October 2012
  Purpose

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
Bronchiolitis
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

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

sputum


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

  Eligibility

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

Criteria

Inclusion Criteria:

  • patients under 2 years of age
  • hospitalized for bronchiolitis

Exclusion Criteria:

  • bronchopulmonary disease
  • congenital heart defect,
  • congenital pulmonary disease,
  • Down's 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: NCT01441466

Locations
Netherlands
Isala Klinieken
Zwolle, Netherlands, 8000GK
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, Pediatrician, Princess Amalia Children's Clinic
ClinicalTrials.gov 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:
bronchiolitis
RSV

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

ClinicalTrials.gov processed this record on July 26, 2014