Yale Pink and Blue Kids: Effects of Exposure During Pregnancy to Nicotine or Antidepressants in 4-8 Year Old Children
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 4 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | October 2011 |
| End Date: | July 2013 |
Yale Pink and Blue Kids: Effects of in Utero Exposure to Nicotine and Selective Serotonin Reuptake Inhibitors in 4-8 Year Old Children
The purpose of this project is to conduct a follow-up study with women that had participated
in the Yale Pink and Blue Study of depression in pregnancy and birth outcomes. The Yale Pink
and Blue Kids Study is a follow-up study with the mothers and also with the children they
were pregnant with in Yale Pink and Blue. These children are now between the ages of 4 and 8
years old, which is a perfect time to look at developmental outcomes in children. This study
will look at children with exposure to nicotine or antidepressants during pregnancy, as well
as children who were not exposed. The investigators hypothesis is that children who were
exposed to either nicotine or antidepressants in pregnancy will have poorer developmental
outcomes than children who were not exposed. The investigators are also interested in
determining whether nicotine exposure or antidepressant exposure results in poorer outcomes.
The investigators specific aims are:
1. To determine whether pre-school and school aged offspring exposed to maternal cigarette
smoking or antidepressants during pregnancy are more likely to have social-emotional
problems compared to children who were not exposed to cigarettes or antidepressants
during pregnancy.
2. To determine whether pre-school and school aged children who were exposed to prenatal
maternal cigarette smoking or antidepressants during pregnancy display cognitive
impairments as compared to children who were not exposed to either prenatal maternal
cigarette smoking or antidepressants.
3. To determine if pre-school and school aged children who were exposed to maternal
prenatal cigarette smoking or antidepressants display impaired motor development as
compared to children who were not exposed to maternal cigarette smoking or
antidepressants in pregnancy.
in the Yale Pink and Blue Study of depression in pregnancy and birth outcomes. The Yale Pink
and Blue Kids Study is a follow-up study with the mothers and also with the children they
were pregnant with in Yale Pink and Blue. These children are now between the ages of 4 and 8
years old, which is a perfect time to look at developmental outcomes in children. This study
will look at children with exposure to nicotine or antidepressants during pregnancy, as well
as children who were not exposed. The investigators hypothesis is that children who were
exposed to either nicotine or antidepressants in pregnancy will have poorer developmental
outcomes than children who were not exposed. The investigators are also interested in
determining whether nicotine exposure or antidepressant exposure results in poorer outcomes.
The investigators specific aims are:
1. To determine whether pre-school and school aged offspring exposed to maternal cigarette
smoking or antidepressants during pregnancy are more likely to have social-emotional
problems compared to children who were not exposed to cigarettes or antidepressants
during pregnancy.
2. To determine whether pre-school and school aged children who were exposed to prenatal
maternal cigarette smoking or antidepressants during pregnancy display cognitive
impairments as compared to children who were not exposed to either prenatal maternal
cigarette smoking or antidepressants.
3. To determine if pre-school and school aged children who were exposed to maternal
prenatal cigarette smoking or antidepressants display impaired motor development as
compared to children who were not exposed to maternal cigarette smoking or
antidepressants in pregnancy.
Inclusion Criteria:
- Women who participated in the Yale Pink and Blue Study and had children born between
2005 and 2008.
- Exposure to SSRIs during pregnancy will be defined as those women with no exposure in
pregnancy and continuous use of SSRIs (defined as taking at least one SSRI during
every trimester).
- Exposure to nicotine will be defined as no exposure (no cigarettes during pregnancy),
light exposure (an average of less than one cigarette a day over pregnancy duration),
and heavy exposure (an average of one cigarette a day over the duration of pregnancy.
Exclusion Criteria:
- Spanish-Speaking women and women who live over a one hour driving distance from Yale
will be considered ineligible.
- Children are not eligible if their mother had gestational exposure to prescription
drugs in the FDA-defined category of D or X, since this can confound our assessment.
- Women with discontinuous use of SSRIs (defined as using SSRIs during pregnancy, but
not every trimester) will also be excluded.
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