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Trial record 32 of 35 for:    "sudden infant death"

Assessing the Impact of Smoke-free Legislation on Perinatal Health in the Netherlands

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ClinicalTrials.gov Identifier: NCT02189265
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : July 14, 2014
Sponsor:
Collaborators:
Maastricht University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
The Netherlands Perinatal Registry (PRN)
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 perinatal outcomes following the phased smoking ban introduction (January 2004 for workplaces; July 2008 for bars and restaurants) workplaces in the Netherlands.

Condition or disease Intervention/treatment
Premature Birth Perinatal Mortality Infant, Low Birth Weight Stillbirth Infant Mortality Sudden Infant Death Infant, Very Low Birth Weight Infant, Small for Gestational Age Other: Smoke-free legislation

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 2069695 participants
Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: Assessing the Impact of Smoke-free Legislation on Perinatal Health in the Netherlands
Study Start Date : January 2000
Actual Primary Completion Date : December 2011
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Full cohort
All singleton births in the Netherlands. Stillbirths are excluded from the denominator for all outcomes other than perinatal mortality, stillbirth and congenital anomalies.
Other: Smoke-free legislation
The intervention under study is the ban on smoking in workplaces, and in bars and restaurants implemented in the Netherlands on January 1st, 2004 and July 1st, 2008, respectively.




Primary Outcome Measures :
  1. Perinatal mortality [ Time Frame: from 24+0 weeks gestation (for stillbirth); up to 7 days postnatally (for early neonatal mortality) ]
    stillbirth (i.e. intrauterine death from 24+0 weeks gestation) or early neonatal mortality (i.e. death within the first 7 days postnatally)

  2. Preterm birth [ Time Frame: gestational age >= 24+0 weeks and <37+0 weeks ]
    live birth with gestational age >= 24+0 weeks and <37+0 weeks

  3. Small for gestational age [ Time Frame: gestational age >= 24+0 weeks ]
    live birth at gestational age >= 24+0 weeks with birth weight below 10th centile


Secondary Outcome Measures :
  1. Stillbirth [ Time Frame: gestational age >= 24+0 weeks ]
    born dead from 24+0 weeks of gestation

  2. Early neonatal mortality [ Time Frame: up to 7 days postnatally after live birth at gestational age >= 24+0 weeks ]
    death within first 7 days after live birth at gestational age >= 24+0 weeks

  3. Very preterm birth [ Time Frame: gestational age >= 24+0 weeks and <32+0 weeks ]
    live birth with gestational age >= 24+0 weeks and <32+0 weeks

  4. Low birth weight [ Time Frame: gestational age >= 24+0 weeks ]
    live birth at gestational age >= 24+0 weeks with birth weight <2500 grams

  5. Very low birth weight [ Time Frame: gestational age >= 24+0 weeks ]
    live birth at gestational age >= 24+0 weeks with birth weight <1500 grams

  6. Very small for gestational age [ Time Frame: gestational age >= 24+0 weeks ]
    live birth at gestational age >= 24+0 weeks with birth weight below 2.3rd centile

  7. Major congenital anomalies [ Time Frame: gestational age >= 24+0 weeks ]
    birth at >= 24+0 weeks of gestation with a major birth defect (birth defects known to be influenced by antenatal smoke exposure based on recent systematic review (Hackshaw 2011))


Biospecimen Description:
None Retained


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Ages Eligible for Study:   up to 1 Week   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All singleton births in the Netherlands. Stillbirths are excluded from the denominator for all outcomes other than stillbirths and congenital anomalies.
Criteria

Data are obtained via The Netherlands Perinatal Registry (PRN) (6). All registered stillbirths and livebirths occurring in the Netherlands between 1 January 2000 and 31 December 2011 are included.

Inclusion Criteria:

  • Singleton birth occurring in the Netherlands between January 1st, 2000 and December 31st, 2011
  • Liveborn (for all outcomes other than stillbirth and congenital anomalies)

Exclusion Criteria:

  • No chromosomal anomalies

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): NCT02189265


Locations
Netherlands
Academic Medical Centre
Amsterdam, Noord Holland, Netherlands
United Kingdom
Centre for Population Health Sciences, The University of Edinburgh
Edinburgh, Midlothian, United Kingdom, EH8 9AG
Sponsors and Collaborators
University of Edinburgh
Maastricht University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
The Netherlands Perinatal Registry (PRN)
Investigators
Principal Investigator: Jasper V Been, MD MPH PhD Allergy and Respiratory Research Group, Centre for Population Health Sciences, The University of Edinburgh, Edinburgh, UK

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jasper Been, Dr., University of Edinburgh
ClinicalTrials.gov Identifier: NCT02189265     History of Changes
Other Study ID Numbers: TRF NR-0166-1.3
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: July 2014

Keywords provided by Jasper Been, University of Edinburgh:
Live birth [MeSH]
Infant [MeSH]
Infant, newborn [MeSH]
Second-hand smoke
Tobacco smoke pollution [MeSH]
Smoke-free
Smoke-free policy [MeSH]

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