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
Study complete
Study complete
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
    Primary completion date:
    2016-23-09
    Observational study model:
    Ecologic or Community
    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)

    This study does not involve prospective enrollment of participants.

    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
    Study complete
    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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