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

This study has been completed.
Sponsor:
Collaborators:
Maastricht University, Maastricht, Netherlands
University of Glasgow
Imperial College London, London, UK
Information provided by (Responsible Party):
Jasper Been, University of Edinburgh
ClinicalTrials.gov Identifier:
NCT02039583
First received: January 16, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  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 University of Edinburgh:

Primary Outcome Measures:
  • low birth weight [ Time Frame: 1 Jan 1995 - 31 Dec 2011 ] [ Designated as safety issue: No ]
    birth weight <2,500 grams

  • stillbirth [ Time Frame: 1 Jan 1995 - 31 Dec 2011 ] [ Designated as safety issue: No ]
    intrauterine death from 24+0 weeks gestation

  • neonatal mortality [ Time Frame: 1 Jan 1995 - 31 Dec 2011 ] [ Designated as safety issue: No ]
    death within the first 28 days of life

  • sudden infant death syndrome (SIDS) [ Time Frame: 1 Jan 2001 - 31 Dec 2011 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    birth weight < 1,500 grams

  • early neonatal mortality [ Time Frame: 1 Jan 1995 - 31 Dec 2011 ] [ Designated as safety issue: No ]
    death within the first week of life

  • late neonatal mortality [ Time Frame: 1 Jan 1995 - 31 Dec 2011 ] [ Designated as safety issue: No ]
    death between 7 and 28 days of life

  • post-neonatal mortality [ Time Frame: 1 Jan 1995 - 31 Dec 2011 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02039583

Locations
United Kingdom
University of Edinburgh
Edinburgh, Midlothian, United Kingdom, EH8 9AG
Sponsors and Collaborators
University of Edinburgh
Maastricht University, Maastricht, Netherlands
University of Glasgow
Imperial College London, London, UK
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
Study First Received: January 16, 2014
Last Updated: January 16, 2014
Health Authority: United Kingdom: National Health Service

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

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

ClinicalTrials.gov processed this record on October 23, 2014