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Impact of Smoke-free Legislation on Early-life Mortality and Low Birth Weight in England

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02039583
First Posted: January 17, 2014
Last Update Posted: January 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Maastricht University
University of Glasgow
Imperial College London
Information provided by (Responsible Party):
Jasper Been, University of Edinburgh
  Purpose
The purpose of this study is to investigate whether there has been a change in low birth weight and perinatal and infant mortality following the July 2007 introduction of a ban on smoking in public places and workplaces in England.

Condition Intervention
Stillbirth Infant Mortality Sudden Infant Death Infant, Low Birth Weight Infant, Very Low Birth Weight Other: Smoke-free legislation

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Official Title: Impact of Smoke-free Legislation on Early-life Mortality and Low Birth Weight in England: a Quasi-experimental Study

Resource links provided by NLM:


Further study details as provided by Jasper Been, University of Edinburgh:

Primary Outcome Measures:
  • low birth weight [ Time Frame: 1 Jan 1995 - 31 Dec 2011 ]
    birth weight <2,500 grams

  • stillbirth [ Time Frame: 1 Jan 1995 - 31 Dec 2011 ]
    intrauterine death from 24+0 weeks gestation

  • neonatal mortality [ Time Frame: 1 Jan 1995 - 31 Dec 2011 ]
    death within the first 28 days of life

  • sudden infant death syndrome (SIDS) [ Time Frame: 1 Jan 2001 - 31 Dec 2011 ]
    death within first year of life with mentioning on the death certificate of ICD-10-U code R95, or R99 with no other specification


Secondary Outcome Measures:
  • very low birth weight [ Time Frame: 1 Jan 1995 - 31 Dec 2011 ]
    birth weight < 1,500 grams

  • early neonatal mortality [ Time Frame: 1 Jan 1995 - 31 Dec 2011 ]
    death within the first week of life

  • late neonatal mortality [ Time Frame: 1 Jan 1995 - 31 Dec 2011 ]
    death between 7 and 28 days of life

  • post-neonatal mortality [ Time Frame: 1 Jan 1995 - 31 Dec 2011 ]
    death between 28 days and 1 year of life


Enrollment: 10291118
Study Start Date: January 1995
Study Completion Date: January 2014
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
full cohort
All singleton births in England. See 'statistical analysis' for denominator specification for individual outcomes.
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 were by law required to be smoke-free. More detail can be found via the link provided at the end of this protocol.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All singleton births in England. See 'statistical analysis' for specification of base population for each outcome.
Criteria

Inclusion Criteria:

  • singleton birth occurring in England between 1 January 1995 and 31 December 2011

Exclusion Criteria:

  • chromosomal anomalies
  • stillbirth (applies to all outcomes other than stillbirth)
  Contacts and Locations
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): NCT02039583


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

Additional Information:
Publications:
Responsible Party: Jasper Been, Dr., University of Edinburgh
ClinicalTrials.gov Identifier: NCT02039583     History of Changes
Other Study ID Numbers: TRF NR-0166-1.2
First Submitted: January 16, 2014
First Posted: January 17, 2014
Last Update Posted: January 17, 2014
Last Verified: January 2014

Keywords provided by Jasper Been, University of Edinburgh:
live birth
infant
infant, newborn
second-hand smoke
tobacco smoke pollution
smoke-free
smoke-free policy

Additional relevant MeSH terms:
Sudden Infant Death
Body Weight
Birth Weight
Stillbirth
Infant Death
Signs and Symptoms
Fetal Death
Pregnancy Complications
Death
Pathologic Processes
Death, Sudden