Clinical trial NCT01640600: Yale Pink and Blue Kids: Effects of Exposure During Pregnancy to Nicotine or Antidepressants in 4-8 Year Old Children
Official title: Yale Pink and Blue Kids: Effects of in Utero Exposure to Nicotine and Selective Serotonin Reuptake Inhibitors in 4-8 Year Old Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Behavioral Problems
Cognitive Problems
Motor Development
Keywords: To determine whether 4-8 year-old children exposed to nicotine or antidepressants in utero have more behavioral problems.
To determine whether 4-8 year-old children exposed to nicotine or antidepressants in utero have more cognitive problems.
To determine whether 4-8 year-old children exposed to nicotine or antidepressants in utero have poorer motor development.
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
name: National Institute on Drug Abuse (NIDA)
First posted: 2012-07-13
Enrollment: 61
Sex: ALL
Minimum age (years): 4
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Each subject is a previous study participant known to this research team who has agreed to be contacted about future studies. We will review only their research records and not medical records in order to determine eligibility. There are no subjects for whom the ability to give informed consent can be questioned. All of the subjects were at least the age of 18 at the time of their initial PAB participation between 2005-2008, and thus are at least age 20 at the present time. All subjects are English speaking.

These are women who participated in the PAB Study (HIC #12394) and delivered a singleton birth (no twins or triplets) between 2005-2008. We are inviting them and their children (now aged 4-8) to participate.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Externalizing and internalizing behavior
timeFrame: 1 year
measure: Cognitive Impairment
timeFrame: 1 year
measure: Fine & Gross Motor Development
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Psychiatry: The PMS, Perinatal, and Postpartum Research Program
state: Connecticut
Study officials:
affiliation: Yale University
name: Megan V Smith, DrPH
role: PRINCIPAL_INVESTIGATOR
References: