ZIRP - Infant Follow-Up Questionnaire

Att. C 6

Form Approved

OMB No. 0920-XXXX

Exp. Date XX/XX/20XX

Site code	Participant code	Pregnant Woman
I I	I I I I	I I

Today’s date: _____/______/________

MM DD YYYY

ZIKV RNA Persistence (ZIRP): Infant Follow-up Questionnaire

1. Study visit #:____________

2. Study visit location:

₁ Pediatrician’s office

₂ Other, specify: _______________________________________________

3. Date of last study visit (mm/dd/yyyy): ____________

4. Have the infant’s last two study related blood draws come out negative for Zika virus infection by rRT-PCR? ₁ Yes ₀ No

TO BE COMPLETED BY INFANT’S PARENT/GUARDIAN

PART I: General Health

Thank you for allowing your infant to participate in this study. We will now like to ask you questions about your infant’s general health since his last study visit. Since your infant’s last study visit (or delivery if this is his first visit)…

5. Have you had any concerns about the health of your infant? ₁ Yes ₀ No

1. If yes, please specify your concerns____________

6. Has your infant visited the emergency room since his/her last visit? ₁ Yes ₀ No

2. If yes, reason of visit____________ Name of facility____________

7. Has your infant been hospitalized since his/her last visit? ₁ Yes ₀ No

3. If yes, reason of hospitalization____________ Name of facility____________

8. Has your infant had an outpatient visit not requiring an ER visit or hospitalization? ₁ Yes ₀ No

If yes, reason of visit____________ Name of facility____________

9. Has your infant had blood taken since his/her last visit? ₁ Yes ₀ No

4. If yes, reason of blood collection____________

10. Has your infant given a urine sample since his/her last visit? ₁ Yes ₀ No

5. If yes, reason of urine collection____________

TO BE COMPLETED BY MEDICAL RECORD ABSTRACTION

PART I: Vitals

11. Infant’s weight? ________  grams  kilograms

12. Infant’s height? ________ centimeters  inches

13. Infant’s head circumference? ________centimeters

PART II: Neurological development

14. Has the baby experienced any of the following since his/her last visit?

6. Apnea ☐₁ Yes ☐₀ No ☐₇₇ Unknown

7. Seizures ☐₁ Yes ☐₀ No ☐₇₇ Unknown

8. Paralysis ☐₁ Yes ☐₀ No ☐₇₇ Unknown

9. Joint Contracture ☐₁ Yes ☐₀ No ☐₇₇ Unknown

10. Floppiness ☐₁ Yes ☐₀ No ☐₇₇ Unknown

11. Other: ☐₁ Yes ☐₀ No ☐₇₇ Unknown

If yes, Specify: ____________

15. Signs of any of the following abnormalities in the infant since his/her last visit?

12. Facial dysmorphia ☐₁ Yes ☐₀ No ☐₇₇ Unknown

13. Eye abnormalities ☐₁ Yes ☐₀ No ☐₇₇ Unknown

14. Ear abnormalities ☐₁ Yes ☐₀ No ☐₇₇ Unknown

15. Excess head skin ☐₁ Yes ☐₀ No ☐₇₇ Unknown

16. Reduced size of the skull ☐₁ Yes ☐₀ No ☐₇₇ Unknown

17. Down syndrome features ☐₁ Yes ☐₀ No ☐₇₇ Unknown

18. Other: ☐₁ Yes ☐₀ No ☐₇₇ Unknown

If yes, Specify: ____________

PART III: Microbiology testing

16. Was a blood specimen of the infant taken? ₁ Yes ₀ No

16a. If no, why?

₀ The last two study related blood draws came out negative for Zika virus infection

₁ Other, specify ____________________________________

16b. Date (mm/dd/yyyy)

16c. Time (hh:mm) of specimen collection: ____________

16d. Date specimen was sent to laboratory (mm/dd/yyyy): ____________

16e. Type of test:

₀ RT-PCR

_1. IgM

₂ RT-PCR & IgM

₃ Other

17. Was a urine sample of the baby obtained? ₁ Yes ₀ No

17a. If no, why?

₀ The last two study related urine samples came out negative for Zika virus infection

₁ Other, specify ____________________________________

17b. Date (mm/dd/yyyy)

17c. Time (hh:mm) of specimen collection: ____________

17d. Date specimen was sent to laboratory (mm/dd/yyyy): ____________

17e. Type of test:

₀ RT-PCR

_1. IgM

₂ RT-PCR & IgM

₃ Other

PART IV: Study Termination

18. Was data collection concluded for this infant for the study? ₁ Yes ₀ No

18a₁. If yes, reason:

₀ Last two sample collections tested negative for Zika confirmed by RT-PCR

₁ End of study period

₂ Admitted to hospital for adverse outcomes

₃ Withdrawn from study by guardian

₄ Terminated by study staff

₅ Other, specify ____________________________________

18a_2. If yes, date of study termination (mm/dd/yyyy): ____________

Public reporting burden of this collection of information is estimated to average 8 minutes, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.  Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-74,  Atlanta, Georgia 30333; ATTN:  PRA (0920-1189).