Cohort Isolation and Cross-infection in Bronchiolitis

NCT01441466 | Completed Results

• 1 other identifier: bronchiolitis
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Bronchiolitis

Keywords

bronchiolitis; RSV

Outcome Measures

Primary Outcomes (1)

• Duration of Hospital Stay

  duration of hospitalisation, an average of 3-4 days

Secondary Outcomes (5)

• Number of Days With Tube Feeding

  duration of hospitalisation, an average of 3-4 days

• Supplemental Oxygen Needed

  duration of hospitalisation, an average of 3-4 days

• Highest Dyspnoea Score

  duration of hospitalisation, an average of 3-4 days

• Mechanical Ventilation

  duration of hospitalisation, an average of 3-4 days

• Cross-infection

  measured until 1 week after hospital exit

Study Arms (2)

Group without isolation

Patients in this arm are nursed together (in the same room) independent of viral agent.

Other: Isolation

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

Interventions

Isolation OTHER

Patients in this arm are nursed together (in the same room) independent of viral agent

Group without isolation

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants admittted for bronchiolitis under 2 years of age

You may qualify if:

• patients under 2 years of age
• hospitalized for bronchiolitis

You may not qualify if:

• bronchopulmonary disease
• congenital heart defect,
• congenital pulmonary disease,
• Down's syndrome

Sponsors & Collaborators

• Princess Amalia Children's Clinic: lead

Study Sites (1)

Isala Klinieken

Zwolle, 8000GK, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

sputum

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Results Point of Contact

• Title: Jolita Bekhof
• Organization: Princess Amlia Children's Clinic, Isala

j.bekhof@isala.nl

+31384245050

Study Officials

• Jolita Bekhof, MD

  Isala

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Pediatrician

Study Record Dates

• First Submitted: September 23, 2011
• First Posted: September 27, 2011
• Study Start: November 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: May 1, 2012
• Last Updated: February 17, 2017
• Results First Posted: July 14, 2015

Record last verified: 2017-01

Locations

NL (1)