The Stress Responses of Fetuses and Infants Whose Mothers Smoked During Pregnancy
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|ClinicalTrials.gov Identifier: NCT00563966|
Recruitment Status : Unknown
Verified November 2007 by Hadassah Medical Organization.
Recruitment status was: Recruiting
First Posted : November 27, 2007
Last Update Posted : May 12, 2008
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 or disease|
|Effects of Smoking on Infant|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||The Stress Responses of Fetuses and Infants Whose Mothers Smoked During Pregnancy: Genes, Hormones and Psychological Modulators|
|Study Start Date :||April 2008|
|Estimated Study Completion Date :||December 2008|
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
|Contact: David Mankuta, MDemail@example.com|
|Hadassah Medical Organization||Recruiting|
|Contact: David Mankuta, MD|
|Sub-Investigator: Rachel Bachner, PhD|
|Study Chair:||Ebstein Richard, MD PhD||Hebrew University Jerusalem Israel|