BronchiolitisNCT01714076
Co-infections in Children Hospitalised for Bronchiolitis
An observational study of Bronchiolitis, run by Princess Amalia Children's Clinic at 1 site in Netherlands.
Trial summary
Observational cohort study in children hospitalized for acute bronchiolitis. Patients are nursed in cohort isolation. Aim is to investigate the incidence and clinical impact of co-infections in this group. Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- cohort isolation
- How many people
- 172 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2012to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: children < 2 years admitted for bronchiolitis
Who may be able to join
- younger than 2 years admitted for bronchiolitis
Who cannot join
- chronic lung disease congenital heart defect down syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Co-infections in Children Hospitalised for Bronchiolitis: Incidence, Clinical Symptoms and Influence of Cohort Isolation
Observational cohort study in children hospitalized for acute bronchiolitis. Patients are nursed in cohort isolation. Aim is to investigate the incidence and clinical impact of co-infections in this group.
Read the detailed description
Observational cohort study in children hospitalized for acute bronchiolitis. Patients are nursed in cohort isolation, meaning that all patients admitted for bronchiolitis are cohorted together, irrespective of viral diagnosis. Aim is to investigate the incidence and clinical impact of co-infections in this group.
- Conditions
- Bronchiolitis
- Being tested
- cohort isolation
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cohort isolationOther
all patients hospitalised for bronchiolitis are nursed in one room together, separated from patients without bronchiolitis
| Study group | Role | What they receive |
|---|---|---|
| cohort isolation | patients with bronchiolitis are cohorted together irrespective of viral agent diagnosed, thus respiratory syncytial virus (RSV)-positive patient stay in the same room as RSV-negative patients Receives: Other: cohort isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
co-infection
co-infection acquired during hospitalisation, patient will be followed during hospitalisation and until 1 week after discharge from the hospital, since average duration of hospitalisation in infants with bronchiolitis is 3 days, the time frame will be approximately 2 weeks
Measured: approximately 2 weeks
Secondary outcomes (1)
clinical severity
clinical severity defined as, days of oxygen supplementation, tube feeding, dyspnea score, length of hospitalisation
Measured: approximately 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Princess Amalia Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jolita Bekhof, Princess Amalia Children's Clinic
- Investigators
- Jolita Bekhof, MD, Principal investigator, Isala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714076
- Sponsor's protocol ID
- JB-3
- Status last verified
- Oct 2015
- First submitted
- 8 Oct 2012
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-infections in Children Hospitalised for Bronchiolitis: Incidence, Clinical Symptoms and Influence of Cohort Isolation
- ClinicalTrials.gov ID
- NCT01714076
- Acronym / sponsor ID
- JB-3
- Conditions
- Bronchiolitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Princess Amalia Children's ClinicUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- May 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 25 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational cohort study in children hospitalized for acute bronchiolitis. Patients are nursed in cohort isolation. Aim is to investigate the incidence and clinical impact of co-infections in this group.
Detailed description
Observational cohort study in children hospitalized for acute bronchiolitis. Patients are nursed in cohort isolation, meaning that all patients admitted for bronchiolitis are cohorted together, irrespective of viral diagnosis. Aim is to investigate the incidence and clinical impact of co-infections in this group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort isolation | – | Other: cohort isolationpatients with bronchiolitis are cohorted together irrespective of viral agent diagnosed, thus respiratory syncytial virus (RSV)-positive patient stay in the same room as RSV-negative patients |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children < 2 years admitted for bronchiolitis
Key inclusion criteria (1 listed)
- younger than 2 years admitted for bronchiolitis
Key exclusion criteria (1 listed)
- chronic lung disease congenital heart defect down syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cohort isolationall patients hospitalised for bronchiolitis are nursed in one room together, separated from patients without bronchiolitis | Other | cohort isolation |
Primary outcome
co-infection
Time frame: approximately 2 weeks
co-infection acquired during hospitalisation, patient will be followed during hospitalisation and until 1 week after discharge from the hospital, since average duration of hospitalisation in infants with bronchiolitis is 3 days, the time frame will be approximately 2 weeks
1 secondary outcome
clinical severity
Time frame: approximately 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jolita Bekhof, MD principal investigator
Isala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiolitis, run by Princess Amalia Children's Clinic at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
co-infection (time frame: approximately 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2015.