Clinical Trial: Cohort Isolation and Cross-infection in Bronchiolitis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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)

Detailed Summary:

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.

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Sponsor: Princess Amalia Children's Clinic

Current Primary Outcome: Duration of Hospital Stay [ Time Frame: duration of hospitalisation, an average of 3-4 days ]

Original Primary Outcome: Duration of Hospital Stay [ Time Frame: 3 months ]

Current Secondary Outcome:

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

Original Secondary Outcome: severity of disease [ Time Frame: 3 months ]

Information By: Princess Amalia Children's Clinic

Dates:
Date Received: September 23, 2011
Date Started: November 2011
Date Completion:
Last Updated: January 2, 2017
Last Verified: January 2017