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

Yale University

Status: Completed

Conditions: Behavioral Problems; Cognitive Problems; Motor Development

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01640600

1105008516

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 4 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

61 participants in 3 patient groups

Children exposed to SSRIs in utero

Description:

This group are comprised of children whose mothers used antidepressants during pregnancy and who were therefore exposed to antidepressants in utero.

Children exposed to nicotine in utero

Description:

This group is comprised of children whose mothers smoked cigarettes during pregnancy and who were therefore exposed to nicotine in utero.

Children exposed to neither nicotine nor SSRIs

Description:

This group is comprised of children who were exposed to neither nicotine nor SSRIs in utero.