NCT01920165

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,660,652

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
11.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2013

Completed
Last Updated

August 13, 2013

Status Verified

August 1, 2013

Enrollment Period

11.9 years

First QC Date

August 5, 2013

Last Update Submit

August 9, 2013

Conditions

Keywords

respiratory tract infectionsupper respiratory tract infectionslower respiratory tract infectionshospitalisationchildchildrenminorsinfantssecond-hand smoketobacco smoke pollutionsmoke-freesmoke-free policysmoke-free legislationpublic places

Outcome Measures

Primary Outcomes (1)

  • rate of unplanned hospital admissions for acute RTIs

    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.

    up to 12 years

Secondary Outcomes (2)

  • rate of unplanned hospital admissions for acute upper RTIs

    up to 12 years

  • rate of unplanned hospital admissions for acute lower RTIs

    up to 12 years

Study Arms (1)

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

Interventions

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

Full cohort

Eligibility Criteria

AgeUp to 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The population at risk for each time point is the number of children living in England aged 0-14 years

You may qualify if:

  • age 0-14 years
  • living in England

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Edinburgh

Edinburgh, Midlothian, EH8 9AG, United Kingdom

Location

Related Publications (5)

  • Jones LL, Hashim A, McKeever T, Cook DG, Britton J, Leonardi-Bee J. Parental and household smoking and the increased risk of bronchitis, bronchiolitis and other lower respiratory infections in infancy: systematic review and meta-analysis. Respir Res. 2011 Jan 10;12(1):5. doi: 10.1186/1465-9921-12-5.

    PMID: 21219618BACKGROUND
  • Jones LL, Hassanien A, Cook DG, Britton J, Leonardi-Bee J. Parental smoking and the risk of middle ear disease in children: a systematic review and meta-analysis. Arch Pediatr Adolesc Med. 2012 Jan;166(1):18-27. doi: 10.1001/archpediatrics.2011.158. Epub 2011 Sep 5.

    PMID: 21893640BACKGROUND
  • Millett C, Lee JT, Laverty AA, Glantz SA, Majeed A. Hospital admissions for childhood asthma after smoke-free legislation in England. Pediatrics. 2013 Feb;131(2):e495-501. doi: 10.1542/peds.2012-2592. Epub 2013 Jan 21.

    PMID: 23339216BACKGROUND
  • Oberg M, Jaakkola MS, Woodward A, Peruga A, Pruss-Ustun A. Worldwide burden of disease from exposure to second-hand smoke: a retrospective analysis of data from 192 countries. Lancet. 2011 Jan 8;377(9760):139-46. doi: 10.1016/S0140-6736(10)61388-8.

    PMID: 21112082BACKGROUND
  • Been JV, Millett C, Lee JT, van Schayck CP, Sheikh A. Smoke-free legislation and childhood hospitalisations for respiratory tract infections. Eur Respir J. 2015 Sep;46(3):697-706. doi: 10.1183/09031936.00014615. Epub 2015 May 28.

Related Links

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • Jasper V Been, MD MPH PhD

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 5, 2013

First Posted

August 9, 2013

Study Start

January 1, 2001

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

August 13, 2013

Record last verified: 2013-08

Locations