1. CIFASD Progress Ukraine Clinical Project February 1-2, 2011
Christina Chambers
Kenneth Lyons Jones
Claire Coles
Julie Kable
Andy Hull
Lyuba Yevtushok
Natalya Zymak
Wladimir Wertelecki

2. Specific Aims
Measure birth prevalence and range of alcohol-related physical features and neurobehavioral impairment relative to dose, timing of exposure to alcohol
Evaluate contribution of maternal nutritional status to outcomes
Baseline and third trimester blood levels
RCT with MMN supplements with or without choline
Provide resources for prenatal ultrasound study

3. Progress: Recruitment and Evaluations in Phase II
7,026 pregnant women screened in two oblasts
390 have completed first interview
596 ultrasounds performed
241 outcome interviews completed
185 Bayley tests completed
157 dysmorphology exams for unique children;280 dysmorphology exams by Ukrainian physicians
514 blood samples received at UC Davis

4. 5/11
7/11
12/11
7/12
Aim 1 - Exposure v Physical Features (+ pilot) ✓
Aim 2 Baseline
Nutrition v Physical Features
Aim 1,2,3 – Neurobehavior 6M
12M
Aim 3 – Exposure v Physical Features (+ pilot)

5. Specific Aim 2: Baseline Mineral Status and Physical Features
Exposure Classification
OR (95% CI) For Cardinal Features of FAS*
p-value
AA per day conception
4.430 (1.338, )
0.015
Fe lower quartile
5.447 (1.721, )
0.004
Zn lower quartile
1.736 (0.570, 5.285)
0.331
Cu lower quartile
0.149 (0.031, 0.720)
0.010
Folic acid supplements
0.271 (0.043, 0.869)
0.018
*Adjusted for smoking, gestational age at enrollment, and CP activity

6. DSMB Met January, 2011 Feedback to participants
Reviewed data Fe levels for subjects in exposed and treated group; determined no evidence of a safety signal
Reviewed progress report and recommended a revision to the analysis plan to allow for a formal interim analysis when sample size of 300 subjects achieved for neurobehavior

7. This Year Added 1 FTE statistician Post-doc nutritional epidemiologist
PhD Math/Stats student
Bringing Smriti up to speed

8. 5 questions 7 children with 4 modes of evaluation
35 children with 3 of 4
Laterality of physical features across modalities?

9. Palpebral Fissure Length
Category
R = L
N = 361 %
R > L
N = 27
L > R
N = 47
FAS
90.3
4.2
5.6
No FAS
82.6
7.7
9.7
Deferred
80.1
5.1
14.7
Deferred: Robinson
68.2
9.1
22.7
Deferred: Hoyme
73.8
4.9
21.3
Deferred: Jones
88.1
4.5
7.5

10. This Year
Modify the startle response protocol to mirror the infant heart rate monitoring paradigm
Population-based estimate of incidence of FAS based on screened sample and rate of affected in exposed sample
Enhance retention and implement a plan to retain the cohort beyond 12 months
Obtain agreement to use selected samples for mRNA biomarker collaboration
Re-consent to use archived blood samples for DNA?
R01 application focused on nutrition PA
Longer term neurobehavior measures for the cohort
Infant nutrition measures
Post-natal intervention