NCT02039583

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10,291,118

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1995

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, 1995

Completed
16.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 17, 2014

Completed
Last Updated

January 17, 2014

Status Verified

January 1, 2014

Enrollment Period

16.9 years

First QC Date

January 16, 2014

Last Update Submit

January 16, 2014

Conditions

StillbirthInfant MortalitySudden Infant DeathInfant, Low Birth WeightInfant, Very Low Birth Weight

Keywords

live birthinfantinfant, newbornsecond-hand smoketobacco smoke pollutionsmoke-freesmoke-free policy

Outcome Measures

Primary Outcomes (4)

  • low birth weight

    birth weight \<2,500 grams

    1 Jan 1995 - 31 Dec 2011

  • stillbirth

    intrauterine death from 24+0 weeks gestation

    1 Jan 1995 - 31 Dec 2011

  • neonatal mortality

    death within the first 28 days of life

    1 Jan 1995 - 31 Dec 2011

  • sudden infant death syndrome (SIDS)

    death within first year of life with mentioning on the death certificate of ICD-10-U code R95, or R99 with no other specification

    1 Jan 2001 - 31 Dec 2011

Secondary Outcomes (4)

  • very low birth weight

    1 Jan 1995 - 31 Dec 2011

  • early neonatal mortality

    1 Jan 1995 - 31 Dec 2011

  • late neonatal mortality

    1 Jan 1995 - 31 Dec 2011

  • post-neonatal mortality

    1 Jan 1995 - 31 Dec 2011

Study Arms (1)

full cohort

All singleton births in England. See 'statistical analysis' for denominator specification for individual outcomes.

Other: Smoke-free legislation

Interventions

Smoke-free legislationOTHER

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.

full cohort

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

All singleton births in England. See 'statistical analysis' for specification of base population for each outcome.

You may qualify if:

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

You may not qualify if:

  • chromosomal anomalies
  • stillbirth (applies to all outcomes other than stillbirth)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Edinburgh

Edinburgh, Midlothian, EH8 9AG, United Kingdom

Location

Related Publications (3)

  • Mackay DF, Nelson SM, Haw SJ, Pell JP. Impact of Scotland's smoke-free legislation on pregnancy complications: retrospective cohort study. PLoS Med. 2012;9(3):e1001175. doi: 10.1371/journal.pmed.1001175. Epub 2012 Mar 6.

    PMID: 22412353BACKGROUND

  • Markowitz S. The effectiveness of cigarette regulations in reducing cases of Sudden Infant Death Syndrome. J Health Econ. 2008 Jan;27(1):106-33. doi: 10.1016/j.jhealeco.2007.03.006. Epub 2007 Apr 8.

    PMID: 17498829BACKGROUND

  • 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

Related Links

MeSH Terms

Conditions

StillbirthInfant DeathSudden Infant Death

Condition Hierarchy (Ancestors)

Fetal DeathPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDeathPathologic ProcessesPathological Conditions, Signs and SymptomsDeath, Sudden

Study Officials

  • Jasper V Been, MD MPH PhD

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 16, 2014

First Posted

January 17, 2014

Study Start

January 1, 1995

Primary Completion

December 1, 2011

Study Completion

January 1, 2014

Last Updated

January 17, 2014

Record last verified: 2014-01

Locations

GB(1)