Attach 6 Study Info

Attach 6 Study Info.doc

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

Attach 6 Study Info

OMB: 0923-0046

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^N^a^v^ajo^B^ir^t^h^Cohort
Study

Helping Your Baby

^and^F^uture^Generations

^T^o^Gr^o^wⁱⁿ^Beauty

If you are a pregnant woman or thinking about becoming pregnant, please consider joining us in this important study.

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 goal of the study is to better understand the relationship between uranium exposures and birth outcomes and early developmental delays on the Navajo Nation. The data from the study may be used to improve future birth outcomes and services.

• Are you pregnant and 14 to 45 years old?

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on^th^e^N^a^v^ajo^N^a^t^ion^f^or^a^t
le^a^s^t⁵^y^e^a^r^s?

^•^Will^y^ou^d^eli^v^er^a^t
oⁿ^e^of^th^ese^f^acili^t^ies?

^{• Chi}ⁿ^le^Com^p^r^e^h^eⁿ^si^v^e^H^e^a^l^t^h^Ca^r^e^F^acili^t^y

^{• Gall}^u^p^In^d^ian^M^e^dⁱ^c^al^Ce^nt^er

^•^N^or^th^ern^N^a^v^ajo^M^e^dⁱ^c^al^Ce^nt^er⁽^S^hⁱ^p^r^o^ck⁾

^•^T^sé^h^oo^t^so^o^í^M^e^dⁱ^c^al^Ce^nt^er⁽^F^t^.^D^e^f^iaⁿ^c^e)

^•^T^ub^a^City^R^egi^on^al^H^e^a^l^t^h^Ca^r^e^Cor^p^o^r^a^t^ion

^•^A^r^e^y^ou^w^illiⁿ^g^t^o^h^a^v^e^y^o^u^r^c^h^ild
iⁿ^v^ol^v^edⁱⁿ^th^is^r^es^e^a^r^c^h^f^or^h^er
or^h^is^fⁱ^r^s^t^y^e^a^r?

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:

^•^Dⁱ^N^EH^P^r^o^je^c^t^(Unⁱ^v^ersity^o^f^N^ew^M^e^x^ico^C^omm^uⁿ^ity^Envir^oⁿ^m^en^t^al^H^ealth^P^r^o^g^ram^aⁿ^d^So^u^thwest^Res^e^arch

^aⁿ^d^Iⁿ^f^o^r^m^ati^oⁿ^Center)^•^Centers^f^o^r^D^isease^C^oⁿ^tr^o^l^aⁿ^d^P^re^v^enti^on/^A^g^en^c^y^f^o^r^T^o^xic^S^ub^stances^D^isease

^Registry^•^N^a^v^ajo^A^r^ea^I^nd^ian^Health^Service^•N^a^v^ajo^N^ati^oⁿ^D^ivisi^oⁿ^o^f^H^ealth

Approved and monitored by

^•^N^a^v^ajo^N^ati^oⁿ^Hu^m^an^Res^e^arch^Re^v^iew^B^o^ard^NN^R^-¹⁰^.3²³

^•^Uⁿ^iv^e^rsity^o^f^N^ew^M^e^x^ico^Hu^m^an^Res^e^arch^Re^v^iew^C^om^mⁱ^t^t^e^e^H^R^P^O#¹¹^-³¹⁰

Funding from CDC/ATSDR: U01 TS000135 Principal Investigator Johnnye Lewis Ph.D.,D.A.B.T.

^A^r^t^wo^rk^b^y^S^and^y^Ra^moⁿ^e

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.

_W_hen	_M_om	_Dad	_Baby	_Re_s_e_ar_ch_T_e_a_m
At Enrollment	Consent	Consent	Mom consents for baby	Provide information and explain study for informed consent
	Urine and blood samples provided during clinic visit	Urine and blood sample		Collect samples
	_F_i_rs_t_s_ur_v_ey	_S_ur_v_ey		_Con_d_u_c_t_s_ur_v_ey
	Home assessment and environmental sampling	Home assessment and environmental sampling		Set up for collection of environmental sampling

At Birth	Urine and blood samples and medical record review		Cord blood, urine, and meconium samples; medical record review	Review of medical record for previous pregnancies, 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)	Administer questionnaire and refer to Growing in Beauty (GIB) if any possible developmental concerns identified; review baby’s medical record

6 months	Survey on infant feeding activities		Assessment of growth, progress, and home environment*; urine collection	Administer questionnaire, collect samples, refer to GIB if needed

9 months	Survey on infant feeding activities		Assessment of growth, progress, and home environment*	Administer questionnaire; refer to GIB if needed

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 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

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aⁿ^d^p^e^r^s^oⁿ^al^s^ocial^s^kill^s^.

^**^At¹²^m^oⁿ^t^h^s^,^we^w^ill^al^s^o^as^s^es^s
o^b^se^r^ve^d^aⁿ^d^s^p^okenⁱⁿ^f^orma^t^ioⁿ^,^aⁿ^d^ve^r^b^al^e^x^p^r^ess^ioⁿ^.

File Type	application/msword
File Title	Slide 1
Author	MDowns
Last Modified By	CTAC
File Modified	2013-02-13
File Created	2013-02-13