Last updated: 06/26/2019 11:20:10

Impact of rotavirus vaccination on hospital pressures at a large paediatric hospital in the UK: an ecological study

GSK study ID
205369
See study documents
Clinicaltrials.gov ID
NCT03271593
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Impact of rotavirus vaccination on hospital pressures at a large paediatric hospital in the UK: an ecological study
Trial description: The impact of rotavirus vaccination on the burden of disease has been well documented. However, the anticipated reduction in hospital pressures has yet to be described. This study will provide quantitative measures of hospital pressure prior to and post vaccine introduction, provide a template for future hospital pressures studies related to vaccine introduction and provide measures which could be used in an economic evaluation.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Change in bed day occupancy (BDO) rates

Timeframe: During the study observation period of 15 years (1st July 2000 – 30th June 2015)

Change in turnover (TO) rates

Timeframe: During the study observation period of 15 years (1st July 2000 – 30th June 2015)

Change in early unplanned readmission (UR) rates

Timeframe: During the study observation period of 15 years (1st July 2000 – 30th June 2015)

Change in rate of nosocomial infections (NOSO)

Timeframe: During the study observation period of 15 years (1st July 2000 – 30th June 2015)

Change in number of rotavirus gastroenteritis (RVAG) tests taken

Timeframe: During the study observation period of 15 years (1st July 2000 – 30th June 2015)

Change in number of positive test results

Timeframe: During the study observation period of 15 years (1st July 2000 – 30th June 2015)

Change in rate of hospitalization in children less that 5 years old

Timeframe: During the study observation period of 15 years (1st July 2000 – 30th June 2015)

Secondary outcomes:

Development of a Quality of Care (QoC) score

Timeframe: During the study observation period of 15 years (1st July 2000 – 30th June 2015)

Interventions:
Other: No intervention
Enrollment:
Not applicable
Observational study model:
Ecologic or Community
Primary completion date:
2016-23-09
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Gastroenteritis
Product
SB444563
Collaborators
Not applicable
Study date(s)
November 2015 to September 2016
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
0 - 15 years
Accepts healthy volunteers
No
  • All children aged ≤15 years being hospitalised (with overnight stay or day clinic) for whatever reason during the study period
  • None
Inclusion and exclusion criteria
Inclusion criteria:
  • All children aged ≤15 years being hospitalised (with overnight stay or day clinic) for whatever reason during the study period
Exclusion criteria:
  • None

Trial location(s)

No location data available.

Study documents

Clinical study report
Available language(s): English
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Scientific result summary
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Finalized
Actual primary completion date
2016-23-09
Actual study completion date
2016-23-09

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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