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The Stress Responses of Fetuses and Infants Whose Mothers Smoked During Pregnancy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2007 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00563966
First Posted: November 27, 2007
Last Update Posted: May 12, 2008
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.
Collaborator:
Hebrew University of Jerusalem
Information provided by:
Hadassah Medical Organization
  Purpose

It is generally understood that smoking during pregnancy has deleterious effects on the developing fetus, although research on smoking during pregnancy has been limited in focus, with most studies focused on birth weight of newborns and children's behavioral disturbances. However, little is known about the neurobiological underpinnings of nicotine-related developmental deficits and even less is known about genetic and environmental factors that may exacerbate the risk for such deficits in some children. In this study, we propose to examine the relation between antenatal exposure to nicotine and infants' stress-responses before and after birth (2-days, 6-months) and its moderation of by family-based stressors and genes related to nicotine metabolism and stress responsivity.

We hypothesize that the risk imposed on infants by antenatal exposure to nicotine is moderated by genotype that influences functioning of the HPA axis, metabolism of nicotine, and stress-levels and parenting that influence the development of neural substrates (HPA axis) and infants' capacity to cope with stress. There is a growing consensus that Gene x Environmental (G x E) interplay likely mediated by epigenetic effects constitute one of the central mechanism by which complex disorders develop. Our proposal offers an exceptional paradigm to explore the association between genes, environment, and G x E interactions on the neural and behavior response of children to stressful challenges.


Condition
Effects of Smoking on Infant

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: The Stress Responses of Fetuses and Infants Whose Mothers Smoked During Pregnancy: Genes, Hormones and Psychological Modulators

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Biospecimen Retention:   Samples With DNA
DNA samples + salivery cortisol

Estimated Enrollment: 200
Study Start Date: April 2008
Estimated Study Completion Date: December 2008
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Women who smoked during pregnancy
Criteria

Inclusion Criteria:

  • Smokes at least 10 cigarettes a day
  • No abuse of alcohol or drugs
  • No chronic physical disability
  • 22-35 years of age
  • Living with partner
  • Speaks English, Hebrew, or Russian
  • Natural conception
  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): NCT00563966


Contacts
Contact: David Mankuta, MD 97226776484 mankutad@gmail.com

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: David Mankuta, MD         
Sub-Investigator: Rachel Bachner, PhD         
Sponsors and Collaborators
Hadassah Medical Organization
Hebrew University of Jerusalem
Investigators
Study Chair: Ebstein Richard, MD PhD Hebrew University Jerusalem Israel
  More Information

Responsible Party: David Mankuta, Hadassah
ClinicalTrials.gov Identifier: NCT00563966     History of Changes
Other Study ID Numbers: smokingmothers-HMO-CTIL
First Submitted: November 25, 2007
First Posted: November 27, 2007
Last Update Posted: May 12, 2008
Last Verified: November 2007

Keywords provided by Hadassah Medical Organization:
smoking pregnancy behaviour polymorphisms