Cohort Isolation and Cross-infection in Bronchiolitis

Cross-infection in Children Hospitalized for Bronchiolitis: Incidence, Symptoms en Effect of Cohort Isolation

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)

Study Overview

• Status: Completed
• Conditions: Bronchiolitis
• Intervention / Treatment: Other: Isolation

Detailed Description

Acute bronchiolitis is a major cause for hospitalisation in young children during the winter season. Human Respiratory Syncytial Virus (RSV) is the most frequently identified virus, however with the use of new and highly sensitive molecular amplification methods, the role of other viral pathogens in bronchiolitis has been increasingly recognized. Various disease severity has been shown for a range of respiratory viruses, and double viral infection is relatively common, occurring in about 10-30% of hospitalised patients. There is no consensus, however, on the impact of such co-infection on disease severity: Some studies showed more severe disease in co-infected children,while others did not.Most hospitals perform routine viral testing to identify and isolate RSV-infected infants, with the aim of reducing the risk of nosocomial cross-infection of other patients.However, no good evidence is available of how effective this approach is in preventing nosocomial cross-infections among admitted patients with the clinical diagnosis of bronchiolitis.

Because of limited isolation facilities, patients with bronchiolitis admitted to our pediatric ward initially share a room, pending the results of virological diagnosis. We hypothesize that contact isolation measures and maintaining enough distance between the beds in a shared room should be sufficient in preventing cross-infection, since the major route of transmission of respiratory viruses is by close contact with infected secretions and not by small-particle aerosol.

Objectives The purpose of this study was to determine the incidence of cross-infection in children hospitalised for bronchiolitis, when patients with RSV share the same room with patients with bronchiolitis infected with another virus during the first day of admission.

Study design The study was conducted at our 30-bed pediatric ward. From December 2011 through March 2012, all eligible infants younger than two years of age hospitalised for acute bronchiolitis were prospectively enrolled. Bronchiolitis was defined as acute respiratory disease, accompanied by coryza, cough, inspiratory crackles and/or expiratory wheezing on auscultation. Infants with chronic lung disease, congenital heart disease and Down's syndrome were excluded.

We prospectively collected the following demographic and clinical information, including presence and number of room mates, virological diagnosis of the patient and room mates, and daily dyspnoea score assessed by an independent researcher, who was unaware of virological diagnosis. A nasopharyngeal aspirate was collected for virological diagnosis by direct immunochromatographic antigen detection immediately at admission, every fourth day during admission, and five to seven days after discharge.All patients with bronchiolitis were treated with standard hygienic measures. Medical and nursing personnel wore gowns, gloves and masks during patient contact and washed their hands before and after patient contact. Parents and visitors were asked to wash hands before leaving the room. On the first day of admission, pending the results of the RSV-PCR (polymerase chain reaction), patients shared a two- or four-bed room, with beds separated at least 1,5 meter. Cohorting of RSV-infected patients commenced as soon as the result of RSV-PCR was known, generally within one day after admission.

Statistical analysis Chi-square test was used to compare categorical data, Mann-Whitney U-tests for continuous data because of skewed distributions. Statistical analyses were performed using Statistical Package for the Social Sciences (SPSS) version 19.

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• Netherlands
  • Zwolle, Netherlands, 8000GK
    • Isala Klinieken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Infants admittted for bronchiolitis under 2 years of age

Description

Inclusion Criteria:

• patients under 2 years of age
• hospitalized for bronchiolitis

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Duration of Hospital Stay	duration of hospitalisation, an average of 3-4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Days With Tube Feeding	number of days the patient has been tube fed	duration of hospitalisation, an average of 3-4 days
Supplemental Oxygen Needed	number of days that supplemental oxygen was needed	duration of hospitalisation, an average of 3-4 days
Highest Dyspnoea Score	highest dyspnoea score (0-10) recorded during admission (0 is no dsypnoea, 10 is highest dyspnoeascore, thus the worst)	duration of hospitalisation, an average of 3-4 days
Mechanical Ventilation	Mechanical ventilation and endotracheal intubation needed	duration of hospitalisation, an average of 3-4 days
Cross-infection	nosocomially acquired cross-infection	measured until 1 week after hospital exit

Collaborators and Investigators

• Sponsor: Princess Amalia Children's Clinic
• Investigators: Principal Investigator: Jolita Bekhof, MD, Isala

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: September 23, 2011
• First Submitted That Met QC Criteria: September 26, 2011
• First Posted (Estimate): September 27, 2011

Study Record Updates

• Last Update Posted (Actual): February 17, 2017
• Last Update Submitted That Met QC Criteria: January 2, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: RSV; bronchiolitis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bronchial Diseases; Iatrogenic Disease; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis; Cross Infection
• Other Study ID Numbers: Bronchiolitis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided