Yale Pink and Blue Kids: Effects of Exposure During Pregnancy to Nicotine or Antidepressants in 4-8 Year Old Children

Completed

Conditions studied: Behavioral Problems, Cognitive Problems, Motor Development

In brief

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.

Key facts

Study ID

NCT01640600

Run by

Yale University

People needed

61

Starts

2011-10-01

Expected to finish

2013-07-01

Last updated by the study team

2017-06-06

Who can join

Age: 4 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Yale Psychiatry: The PMS, Perinatal, and Postpartum Research Program — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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