Att 6 - Study Info and Timeline

Attach#6_Study Info_ParticipTimeline 2-29-12.pdf

Prospective Birth Cohort Study Involving Environmental Uranium Exposure in the Navajo Nation

Att 6 - Study Info and Timeline

OMB: 0923-0046

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Navajo Birth Cohort Study
Helping Your Baby
and Future Generations
To Grow in Beauty
If you are a pregnant woman or thinking
about becoming pregnant, please consider
joining us in this important study.

In the summer of 2012, the Navajo Birth Cohort
Study will be accepting volunteers willing to
participate in the collection of environmental
and biological samples during and after their
pregnancy.
The planned outcome of this study is to provide
the first Navajo Nation-wide documentation of
birth outcomes and developmental delays.
The data from the study may be used to
improve future birth outcomes and services.
• Are you pregnant and 14 to 45 years old?
• Have you lived on the Navajo Nation for at least 5 years?
• Will you deliver at one of these facilities?
• Chinle Comprehensive Health Care Facility
• Gallup Indian Medical Center
• Northern Navajo Medical Center (Shiprock)
• Tséhootsooí Medical Center (Ft. Defiance)
• Tuba City Regional Health Care Corporation
• Are you willing to have your child involved in this research for her or his first year?
If you answered yes to these questions, you are eligible to participate in this research project.

Please call 1-877-545-6775 for more information
and to find out how you can participate
This research is a joint project of:
• DiNEH Project (University of New Mexico Community Environmental Health Program and Southwest Research
and Information Center) • Centers for Disease Control and Prevention/Agency for Toxic Substances Disease
Registry • Navajo Area Indian Health Service •Navajo Nation Division of Health
Approved and monitored by
• Navajo Nation Human Research Review Board NNR-10.323
• University of New Mexico Human Research Review Committee HRPO# 11-310
Funding from CDC/ATSDR: U01 TS000135

Principal Investigator Johnnye Lewis Ph.D.,D.A.B.T.
Artwork by Sandy Ramone

The NBCS is being conducted in response to community questions and concerns
about whether exposure to uranium mining and milling waste is affecting the
outcome of pregnancies or the development of children on Navajo Nation. The
project is a collaboration among the University of New Mexico’s DiNEH Project,
CDC/ATSDR, Navajo Area Indian Health Service, and the Navajo Nation Division of
Health. This table is to help you understand what will happen and when.
When
At Enrollment

Mom
Consent

Dad
Consent

Urine and blood
samples provided
during clinic visit
First survey
Home assessment
and environmental
sampling

Urine and blood
sample

Baby
Mom consents for
baby

Survey
Home
assessment
and
environmental
sampling

Research Team
Provide information and
explain study for informed
consent
Collect samples

Conduct survey
Set up for collection of
environmental sampling

At Birth

Urine and blood
samples and
medical record
review

Cord blood, urine, and Review of medical record for
meconium samples;
previous pregnancies,
medical record review prenatal history for current
pregnancy, labor and delivery
information; collection of
blood and urine samples

2 months

Second survey;
repeat home
assessment and
environmental
sampling if mother
moved during
pregnancy

Assessment of growth,
progress, and home
environment*;
medical record review;
blood collection (finger
or heel stick)

6 months

Survey on infant
feeding activities

Assessment of growth, Administer questionnaire,
progress, and home
collect samples, refer to GIB
environment*; urine
if needed
collection

9 months

Survey on infant
feeding activities

Assessment of growth, Administer questionnaire;
progress, and home
refer to GIB if needed
environment*

12 months

Follow-up survey
on infant feeding
and parenting
activities

Assessments of
growth, progress**,
home environment*;
blood collection (heel
or finger puncture) and
urine sample

Administer questionnaire and
refer to Growing in Beauty
(GIB) if any possible
developmental concerns
identified; review baby’s
medical record

Administer both
questionnaires, collect
samples; refer to GIB if
needed; review baby’s
medical record

*At 2, 6, 9, and 12 months, growth will be assessed by measurements such as length and weight; progress by a screening
questionnaire to assess baby’s communication, gross and fine motor skills, problem solving and personal social skills.
**At 12 months, we will also assess observed and spoken information, and verbal expression.


File Typeapplication/pdf
File TitleSlide 1
AuthorMDowns
File Modified2012-03-16
File Created2012-02-29

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