BronchiolitisOIPPNCT03663660
Organizational Infrastructure Pediatric Plan in Bronchiolitis Epidemics
An observational study of Bronchiolitis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Acute bronchiolitis is a frequent respiratory viral infection of infants, responsible for 460,000 new cases per year in France. Over the years, the number of hospitalizations during the epidemic season appears to be increasing. Bronchiolitis epidemics lead to recurrent hospital disruption. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Organizational infrastructure pediatric plan (OIPP)
- How many people
- 1,636 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2018to 19 Jun 2018
- 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 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Chidren under 2 years hospitalized for bronchiolitis
Who may be able to join
- age < 2 years
- hospitalization for bronchiolitis
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Design of an Organizational Infrastructure Pediatric Plan to Deal With Bronchiolitis Epidemics: Impact on Length of Stay and Quality of Care in a Tertiary Care Regional Hospital
Acute bronchiolitis is a frequent respiratory viral infection of infants, responsible for 460,000 new cases per year in France. Over the years, the number of hospitalizations during the epidemic season appears to be increasing. Bronchiolitis epidemics lead to recurrent hospital disruption. The current trend towards a reduction of hospital beds is exacerbating the pressure on bronchiolitis epidemics on healthcare systems.
In this context, the pediatric departments of Montpellier University Hospital, France, designed in 2014 a common organizational infrastructure pediatric plan (OIPP) to to adapt to these multiple constraints while respecting the quality of care.
Read more
This plan includes a referral flowchart for hospitalized children, an increase in medical and paramedical staff and a restructuring of the pediatric units, with a specific stratification into 4 levels of care.
The study aims to assess the impact of our OIPP on the overall length of stay for children hospitalized for bronchiolitis. The investigator also intend to measure the impact of the OIPP on the length of stay within each unit, the number of transfers from one unit to the other and the number of readmissions within 30 days after hospital discharge. The cost of the implementation of the OIPP in the structure will be analyzed.
Read the detailed description
The investigator compared data between two periods of time, e.g. the two consecutive years before the beginning of the OIPP (winters 2012-2013 and 2013-2014) and two first years after the beginning of the OIPP (winters 2015-2016 and 2016-2017).
- Conditions
- Bronchiolitis
- Being tested
- Organizational infrastructure pediatric plan (OIPP)
- Keywords
- Bronchiolitis, Health care, Organizational change, children, Epidemic, cost
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organizational infrastructure pediatric plan (OIPP)Other
Restructuration of the hospital sectors with a stratification of health care into 4 levels.
| Study group | Role | What they receive |
|---|---|---|
| before the OIPP | Period 1 : Children hospitalized before the OIPP implementation | |
| after the OIPP implementation | Period 2 :Children hospitalized after the OIPP implementation Receives: Other: Organizational infrastructure pediatric plan (OIPP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall hospital length of stay
Overall hospital length of stay
Measured: 1 year
Secondary outcomes (4)
Hospitalization rate in ICU
Rate of hospitalization in intensive care unit
Measured: 1 year
Readmissions within 30 days after hospital discharge
Number of readmissions in our hospital in the 30 days after hospital discharge
Measured: 30 days
Transfer rate between units
Transfer rate between units
Measured: 1 year
Cost of the OIPP implementation in our institution
Cost of the OIPP implementation in our institution
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start1 Apr 2018
- Primary completion1 May 2018
- Study completion19 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Retrospective
- Enrolment
- 1,636 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal AMEDRO, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663660
- Sponsor's protocol ID
- RECHMPL18_0174
- Acronym
- OIPP
- Status last verified
- Jun 2018
- First submitted
- 20 Jun 2018
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Lavilledieu D, Abassi H, Mercier G, Guiraud M, Chaffaut GD, Milesi C, Cambonie G, Gavotto A, Jeziorski E, Amedro P. Implementation of an organizational infrastructure paediatric plan adapted to bronchiolitis epidemics. J Infect Public Health. 2020 Feb;13(2):167-172. doi: 10.1016/j.jiph.2019.07.007. Epub 2019 Aug 2.
PubMed 31378693
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design of an Organizational Infrastructure Pediatric Plan to Deal With Bronchiolitis Epidemics: Impact on Length of Stay and Quality of Care in a Tertiary Care Regional Hospital
- ClinicalTrials.gov ID
- NCT03663660
- Acronym / sponsor ID
- OIPP / RECHMPL18_0174
- Conditions
- Bronchiolitis
- Keywords
- Bronchiolitis, Health care, Organizational change, children, Epidemic, cost
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,636 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 19 Jun 2018 (actual)
- First posted
- 10 Sep 2018 (actual)
- 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.
Acute bronchiolitis is a frequent respiratory viral infection of infants, responsible for 460,000 new cases per year in France. Over the years, the number of hospitalizations during the epidemic season appears to be increasing. Bronchiolitis epidemics lead to recurrent hospital disruption. The current trend towards a reduction of hospital beds is exacerbating the pressure on bronchiolitis epidemics on healthcare systems.
In this context, the pediatric departments of Montpellier University Hospital, France, designed in 2014 a common organizational infrastructure pediatric plan (OIPP) to to adapt to these multiple constraints while respecting the quality of care.
This plan includes a referral flowchart for hospitalized children, an increase in medical and paramedical staff and a restructuring of the pediatric units, with a specific stratification into 4 levels of care.
The study aims to assess the impact of our OIPP on the overall length of stay for children hospitalized for bronchiolitis. The investigator also intend to measure the impact of the OIPP on the length of stay within each unit, the number of transfers from one unit to the other and the number of readmissions within 30 days after hospital discharge. The cost of the implementation of the OIPP in the structure will be analyzed.
Detailed description
The investigator compared data between two periods of time, e.g. the two consecutive years before the beginning of the OIPP (winters 2012-2013 and 2013-2014) and two first years after the beginning of the OIPP (winters 2015-2016 and 2016-2017).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| before the OIPP | – | –Period 1 : Children hospitalized before the OIPP implementation |
| after the OIPP implementation | – | Other: Organizational infrastructure pediatric plan (OIPP)Period 2 :Children hospitalized after the OIPP implementation |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Chidren under 2 years hospitalized for bronchiolitis
Key inclusion criteria (2 listed)
- age < 2 years
- hospitalization for bronchiolitis
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Organizational infrastructure pediatric plan (OIPP)Restructuration of the hospital sectors with a stratification of health care into 4 levels. | Other | after the OIPP implementation |
Primary outcome
Overall hospital length of stay
Time frame: 1 year
Overall hospital length of stay
4 secondary outcomes
Hospitalization rate in ICU
Time frame: 1 year
Readmissions within 30 days after hospital discharge
Time frame: 30 days
Transfer rate between units
Time frame: 1 year
Cost of the OIPP implementation in our institution
Time frame: 1 year
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 10 Sep 2018.
- Derived from this study: PubMed 31378693Lavilledieu D, Abassi H, Mercier G, Guiraud M, Chaffaut GD, Milesi C, Cambonie G, Gavotto A, Jeziorski E, Amedro P. Implementation of an organizational infrastructure paediatric plan adapted to bronchiolitis epidemics. J Infect Public Health. 2020 Feb;13(2):167-172. doi: 10.1016/j.jiph.2019.07.007. Epub 2019 Aug 2.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Bronchiolitis
RecruitingPhase 1
Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD
Graft Versus Host Disease (cGvHD)
Recruiting
RSV Burden in Outpatient and Hospital Settings
RSV Infection, Children, Only
Not yet recruiting
Short-Term Enteral Nutrition for Infants With Bronchiolitis in Pediatric Emergency Departments
Bronchiolitis, Clinical Phenotype
Not yet recruitingPhase 1/2
A Study of Sequential Therapy With AHB-137 Injection Followed by TVAX-008 Injection in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B
Recruiting
Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
Post-Surgical Pain, Chronic, Post-traumatic Pain, Chronic
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.
Pascal AMEDRO, MD, PhD principal investigator
University Hospital, Montpellier
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 University Hospital, Montpellier at 1 site in France.
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 2 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 10 Sep 2018. 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 France. 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?
Overall hospital length of stay (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03663660, which also lists 1 linked publication.
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 10 Sep 2018.