Clinical Trials Directory

Trials / Completed

CompletedNCT01640600

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

Yale Pink and Blue Kids: Effects of in Utero Exposure to Nicotine and Selective Serotonin Reuptake Inhibitors in 4-8 Year Old Children

Status
Completed
Phase
Study type
Observational
Enrollment
61 (actual)
Sponsor
Yale University · Academic / Other
Sex
All
Age
4 Years – 65 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Timeline

Start date
2011-10-01
Primary completion
2013-07-01
Completion
2013-07-01
First posted
2012-07-13
Last updated
2017-06-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01640600. Inclusion in this directory is not an endorsement.