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Smoking Ban and Paediatric Hospital Admissions for Respiratory Tract Infections in England

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ClinicalTrials.gov Identifier: NCT01920165
Recruitment Status : Completed
First Posted : August 9, 2013
Last Update Posted : August 13, 2013
Sponsor:
Collaborators:
Imperial College London
Maastricht University
Information provided by (Responsible Party):
Jasper Been, University of Edinburgh

Brief Summary:
The purpose of this study is to investigate whether there has been a change in the number of hospital admissions for respiratory tract infections among children following the July 2007 introduction of a ban on smoking in public places in England.

Condition or disease Intervention/treatment
Respiratory Tract Infections Upper Respiratory Tract Infections Lower Respiratory Tract Infections Other: Smoke-free legislation

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Study Type : Observational
Actual Enrollment : 1660652 participants
Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: Smoke-free Legislation in England and Hospital Admissions for Respiratory Tract Infections Among Children
Study Start Date : January 2001
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Full cohort
The population at risk for each time point is the number of children living in England aged 0-14 year
Other: Smoke-free legislation
The intervention under study is the smoke-free legislation in England introduced overnight on 1 July 2007. As of this date virtually all enclosed public places and workplaces are by law required to be smoke-free. More detail can be found at: http://www.smokefreeengland.co.uk




Primary Outcome Measures :
  1. rate of unplanned hospital admissions for acute RTIs [ Time Frame: up to 12 years ]

    The primary outcome is the rate of unplanned hospital admissions for acute RTIs. The following International Classification of Diseases (ICD)-10 codes will be used to identify acute RTIs:

    URTIs: A37, H66-H67, J02.0, J00-J06, J09-J11 (excluding J10.0, J11.0) LRTIs: J10.0, J11.0, J12-J18, J20-J22, J40-J42

    Only unplanned hospitalisations where either a primary or first secondary diagnosis of an acute RTI is recorded, will be included. Admissions with a primary diagnosis of asthma are excluded to prevent overlap with a previous study assessing the impact of the English smoking ban on paediatric asthma hospitalisations. Transfers between hospitals following initial admission will not be included. As a unique patient identifier is not available in the source database, it is not possible to distinguish between first and subsequent admissions for individual children.



Secondary Outcome Measures :
  1. rate of unplanned hospital admissions for acute upper RTIs [ Time Frame: up to 12 years ]

    Secondary outcomes include the rate of unplanned hospital admissions for acute upper RTIs (URTIs), and the rate of unplanned hospital admissions for acute lower RTIs (LRTIs). Admissions containing both a diagnosis of an URTI and a LRTI will be counted as a LRTI only. The secondary outcomes are thus mutually exclusive. Please refer to primary outcome for diagnostic ICD-codes.

    Only unplanned hospitalisations where either a primary or first secondary diagnosis of an acute RTI is recorded, will be included. Admissions with a primary diagnosis of asthma are excluded to prevent overlap with a previous study assessing the impact of the English smoking ban on paediatric asthma hospitalisations. Transfers between hospitals following initial admission will not be included. As a unique patient identifier is not available in the source database, it is not possible to distinguish between first and subsequent admissions for individual children.


  2. rate of unplanned hospital admissions for acute lower RTIs [ Time Frame: up to 12 years ]

    Secondary outcomes include the rate of unplanned hospital admissions for acute upper RTIs (URTIs), and the rate of unplanned hospital admissions for acute lower RTIs (LRTIs). Admissions containing both a diagnosis of an URTI and a LRTI will be counted as a LRTI only. The secondary outcomes are thus mutually exclusive. Please refer to primary outcome for diagnostic ICD-codes.

    Only unplanned hospitalisations where either a primary or first secondary diagnosis of an acute RTI is recorded, will be included. Admissions with a primary diagnosis of asthma are excluded to prevent overlap with a previous study assessing the impact of the English smoking ban on paediatric asthma hospitalisations. Transfers between hospitals following initial admission will not be included. As a unique patient identifier is not available in the source database, it is not possible to distinguish between first and subsequent admissions for individual children.




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Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The population at risk for each time point is the number of children living in England aged 0-14 years
Criteria

Inclusion Criteria:

  • age 0-14 years
  • living in England

Exclusion Criteria:

  • hospital admissions with primary diagnosis of asthma
  • transfers between hospitals

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920165


Locations
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United Kingdom
University of Edinburgh
Edinburgh, Midlothian, United Kingdom, EH8 9AG
Sponsors and Collaborators
University of Edinburgh
Imperial College London
Maastricht University
Investigators
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Principal Investigator: Jasper V Been, MD MPH PhD University of Edinburgh

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jasper Been, Dr., University of Edinburgh
ClinicalTrials.gov Identifier: NCT01920165     History of Changes
Other Study ID Numbers: TRF NR-0166-1
First Posted: August 9, 2013    Key Record Dates
Last Update Posted: August 13, 2013
Last Verified: August 2013

Keywords provided by Jasper Been, University of Edinburgh:
respiratory tract infections
upper respiratory tract infections
lower respiratory tract infections
hospitalisation
child
children
minors
infants
second-hand smoke
tobacco smoke pollution
smoke-free
smoke-free policy
smoke-free legislation
public places

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases