Skip to content

Cohort Isolation and Cross-infection in Bronchiolitis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01441466
Enrollment
48
Registered
2011-09-27
Start date
2011-11-30
Completion date
2012-05-31
Last updated
2017-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis

Keywords

bronchiolitis, RSV

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 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.

Interventions

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

Sponsors

Princess Amalia Children's Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 24 Months
Healthy volunteers
No

Inclusion criteria

* patients under 2 years of age * hospitalized for bronchiolitis

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Duration of Hospital Stayduration of hospitalisation, an average of 3-4 days

Secondary

MeasureTime frameDescription
Number of Days With Tube Feedingduration of hospitalisation, an average of 3-4 daysnumber of days the patient has been tube fed
Supplemental Oxygen Neededduration of hospitalisation, an average of 3-4 daysnumber of days that supplemental oxygen was needed
Highest Dyspnoea Scoreduration of hospitalisation, an average of 3-4 dayshighest dyspnoea score (0-10) recorded during admission (0 is no dsypnoea, 10 is highest dyspnoeascore, thus the worst)
Mechanical Ventilationduration of hospitalisation, an average of 3-4 daysMechanical ventilation and endotracheal intubation needed
Cross-infectionmeasured until 1 week after hospital exitnosocomially acquired cross-infection

Countries

Netherlands

Participant flow

Recruitment details

Of 84 eligible patients, 48 were included in the study

Participants by arm

ArmCount
Group Without Isolation
Patients in this arm are nursed together (in the same room) independent of viral agent.
37
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
11
Total48

Baseline characteristics

CharacteristicGroup With IsolationGroup Without IsolationTotal
Age, Categorical
<=18 years
11 Participants37 Participants48 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous0.6 years
STANDARD_DEVIATION 0.5
0.4 years
STANDARD_DEVIATION 0.4
0.5 years
STANDARD_DEVIATION 0.4
Gender
Female
5 Participants17 Participants22 Participants
Gender
Male
6 Participants20 Participants26 Participants
Region of Enrollment
Netherlands
11 participants37 participants48 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 370 / 11
serious
Total, serious adverse events
0 / 370 / 11

Outcome results

Primary

Duration of Hospital Stay

Time frame: duration of hospitalisation, an average of 3-4 days

ArmMeasureValue (MEAN)Dispersion
Group Without IsolationDuration of Hospital Stay3.9 daysStandard Deviation 3.6
Group With IsolationDuration of Hospital Stay2.1 daysStandard Deviation 1.2
Secondary

Cross-infection

nosocomially acquired cross-infection

Time frame: measured until 1 week after hospital exit

ArmMeasureValue (NUMBER)
Group Without IsolationCross-infection0 participants
Group With IsolationCross-infection2 participants
Secondary

Highest Dyspnoea Score

highest dyspnoea score (0-10) recorded during admission (0 is no dsypnoea, 10 is highest dyspnoeascore, thus the worst)

Time frame: duration of hospitalisation, an average of 3-4 days

ArmMeasureValue (MEAN)Dispersion
Group Without IsolationHighest Dyspnoea Score3.4 units on a scale (0-10)Standard Deviation 2.1
Group With IsolationHighest Dyspnoea Score2.9 units on a scale (0-10)Standard Deviation 1.7
Secondary

Mechanical Ventilation

Mechanical ventilation and endotracheal intubation needed

Time frame: duration of hospitalisation, an average of 3-4 days

ArmMeasureValue (NUMBER)
Group Without IsolationMechanical Ventilation2 participants
Group With IsolationMechanical Ventilation1 participants
Secondary

Number of Days With Tube Feeding

number of days the patient has been tube fed

Time frame: duration of hospitalisation, an average of 3-4 days

ArmMeasureValue (MEAN)Dispersion
Group Without IsolationNumber of Days With Tube Feeding2.2 daysStandard Deviation 3.5
Group With IsolationNumber of Days With Tube Feeding0.7 daysStandard Deviation 1.3
Secondary

Supplemental Oxygen Needed

number of days that supplemental oxygen was needed

Time frame: duration of hospitalisation, an average of 3-4 days

ArmMeasureValue (MEAN)Dispersion
Group Without IsolationSupplemental Oxygen Needed2.1 daysStandard Deviation 2.6
Group With IsolationSupplemental Oxygen Needed1.1 daysStandard Deviation 1.6

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026