Infant Follow-Up Questionnaire - English

Zika Virus RNA Persistence in Pregnant Women and Congenitally Exposed Infants in Puerto Rico (ZIRP)

Att C6- Infant Follow-Up Questionnaire

Infant Follow-Up Questionnaire

OMB: 0920-1189

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Form Approved

OMB Control No.: 0920-XXXX

Expiration date: XX/XX/XXXX


Site code

Participant code

Infant Number

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 #:____________


  1. Study visit location:


1 Pediatrician’s office

2 Other, specify: _______________________________________________



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



  1. 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

Shape1


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)…


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

      1. If yes, please specify your concerns____________



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

      1. If yes, reason of visit____________ Name of facility____________


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

      1. If yes, reason of hospitalization____________ Name of facility____________


  1. 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____________


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

      1. If yes, reason of blood collection____________


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

      1. If yes, reason of urine collection____________



TO BE COMPLETED BY MEDICAL RECORD ABSTRACTION

Shape2


PART I: Vitals


  1. Infant’s weight? ________ grams kilograms

  2. Infant’s height? ________ centimeters inches

  3. Infant’s head circumference? ________centimeters


PART II: Neurological development



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

      1. Apnea 1 Yes 0 No 77 Unknown

      2. Seizures 1 Yes 0 No 77 Unknown

      3. Paralysis 1 Yes 0 No 77 Unknown

      4. Joint Contracture 1 Yes 0 No 77 Unknown

      5. Floppiness 1 Yes 0 No 77 Unknown

      6. Other: 1 Yes 0 No 77 Unknown

If yes, Specify: ____________


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

      1. Facial dysmorphia 1 Yes 0 No 77 Unknown

      2. Eye abnormalities 1 Yes 0 No 77 Unknown

      3. Ear abnormalities 1 Yes 0 No 77 Unknown

      4. Excess head skin 1 Yes 0 No 77 Unknown

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

      6. Down syndrome features 1 Yes 0 No 77 Unknown

      7. 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 ____________________________________


18a2. If yes, date of study termination (mm/dd/yyyy): ____________




Page 6 of 6

Version No.12.0

Public reporting burden of this collection of information is estimated to average 8 minutes per response, 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 Information Collection Review Office, 1600 Clifton Road NE, MS D-74,  Atlanta, Georgia 30333; ATTN:  PRA (xxx-xxxx).


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