ZIRP - Infant Baseline and Delivery Questionnaire

Att. C 5

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 Baseline and Delivery Questionnaire

TO BE COMPLETED THROUGH MEDICAL RECORD ABSTRACTION

PART I: Enrollment

Clinic Information	Infant Information
Clinic name: _____________________________	Last name: _____________________________
Municipality*: _____________________________	First name: _____________________________
Study site # (if applicable): ___________________

1. Did the infant’s parent(s) sign informed consent for participation? □₁Yes □₀ No

If yes, date when informed consent was signed (mm/dd/yyyy): ______________________

If no, reason: ______________________

2. What is the mother’s study identifier number? ___- ___ ___ ___ - 0

3. What date was the mother enrolled (mm/dd/yyyy)? ____________

4. What is the infant’s study identifier number? ___ - ___ ___ ___- ___ (corresponding infant number: 1 for first, 2 for second)

PART II: Delivery

5. Infant’s birthdate? __ __/__ __ /__ __ __ __ ₇₇ Don’t know

M M D D Y Y Y Y

6. Gestational age at time of birth? ________ weeks ______ days

7. What was the basis of the gestational age at birth?

₁ Last menstrual period

₂ Ultrasound

₃ Assisted reproduction

₄ Other

8. Infant’s sex? ₁ Male ₀ Female

9. Infant’s birth weight (<12 hours after delivery)? ________ grams kilograms  pounds ₇₇ Don’t know

10. Infant’s crown-to-heel length? ________ inches  centimeters ₇₇ Don’t know

11. Infant’s head circumference (Occipito-frontal after 24h following birth)? ________ centimeters ₇₇ Don’t know

12. Infant’s APGAR score?

1 minutes after birth________, ₇₇ Don’t know

5 minutes after birth________, ₇₇ Don’t know

10 minutes after birth________, ₇₇ Don’t know

13. Infant’s maximum temperature at birth: °C or °F

₁ Oral ₂ Tympanic ₃Rectal ₄ Axillary

14. How was the infant delivered? (tick one box)

₁ Vaginal spontaneous

₂ Vaginal assisted (eg. forceps, vaccuum)

₃ Caesarian section

₄ Assisted Breach

₇₇ Don’t know

15. What was the fetal presentation of the infant at delivery? (tick one box)

₁ Cephalic

₂ Breech

₃ Other

16. Where was the infant delivered? (tick one box)

₁ Home

₂ Health facility

₇₇ Don’t know

17. Were there intra-partum complications? ₁ Yes ₀ No ₇₇ Don’t know

18. Were there post-partum complications? ₁ Yes ₀ No ₇₇ Don’t know

19. Please indicate the infant has had of any of the following conditions by marking “yes”, “no” or ”I don’t know”. If you mark yes in any of the conditions please fill out the fourth column to the right of each individual condition.

	Yes	No	I don’t know	If yes……,
Seizures				1 General 2 Focal
Paralysis				1 General 2 Ascending
Increased stiffness in limbs				Describe: _______
Floppiness (hypotonia)				Describe: _______
Joint contractures				Describe: _______
Other neurological signs				Describe: _______
Oedema				Describe: _______
Apnea				Describe: _______
Rash				Type of rash: _______ Date of rash onset (mm/dd/yyyy): _______
Other abnormal skin condition				Type: Date of onset (mm/dd/yyyy): _______

20.Please indicate if any of the following birth abnormalities were present ≤ 24 post-delivery by marking “yes”, “no” or ”I don’t know” for each one.

	Yes	No	I don’t know
Facial Dysmorphia
Cleft lip/palate
Eye abnormalities
Ear abnormalities
Excess head skin
Small skull (Craniosynostosis)
Down syndrome features
Enlarged back of the head
Congenital heart defects
Lump under the skin (Haemangionmas)
Umbilical hernia
Abdominal wall defect

21. Please indicate if any of the following birth abnormalities were present ≤ 24 post-delivery by marking “yes”, “no” or ”I don’t know” for each one. If you mark yes in any of the conditions please fill out the fourth column to the right of each individual condition.

	Yes	No	I don’t know	If yes,
Hand abnormalities				☐1Missing fingers ☐2Curving of the little finger towards ring finger ☐3Other
Foot abnormalities				☐1Wide spaced toes ☐2Clubfoot ☐3Other
Upper limb abnormalities				Describe: ___________
Lower limb abnormalities				Describe: ___________

22. Was imaging performed on the infant within 24 hours after birth? ₁ Yes ₀ No ₇₇ Don’t know

If yes, what type? (tick box)

₁ Cranial ultrasound scan

Result: ₁ Normal ₂ Abnormal

₂ CT scan

Result: ₁ Normal ₂ Abnormal

₃ MRI

Result: ₁ Normal ₂ Abnormal

₄ Other

Result: ₁ Normal ₂ Abnormal

PART III: Microbiology testing

23. Was a blood specimen taken? ₁ Yes ₀ No

23a. If no, why?

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

₁ Other, specify ____________________________________

23b. If yes,

23.b.1. Date of specimen collection (mm/dd/yyyy): ____________

23.b.2 Time of specimen collection (hh:mm): ____________

23.b.3. Date specimen was sent to laboratory (mm/dd/yyyy): ____________

23.b.4. Type of test:

₀ RT-PCR

_1. IgM

_2. RT-PCR & IgM

₃ Other

24. Was a urine sample taken? ₁ Yes ₀ No

24a. If no, why?

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

₁ Other, specify ____________________________________

24.b. If yes,

24.b.1. Date of specimen collection (mm/dd/yyyy): ____________

24.b.2 Time of specimen collection (hh:mm): ____________

24.b.3. Date specimen was sent to laboratory (mm/dd/yyyy): ____________

24.b.4. Type of test:

₀ RT-PCR

_1. IgM

_2. RT-PCR & IgM

₃ Other

25. Was a cerebrospinal fluid (CSF) sample taken from the infant after birth? ₁ Yes ₀ No ₇₇ Don’t know

If yes, Date (mm/dd/yyyy): ____________

If yes, Fluid appearance: ₁ Clear and colourless ₂ Cloudy ₃ Blood stained ₄ Unknown

26. Was a pediatrician identified for the follow-up of the infant? ₁ Yes ₀ No

If no, why not? ____________________________________

NOTE: A PEDIATRICIAN MUST BE IDENTIFIED BY THE STUDY STAFF PRIOR TO THE INFANTS DEPARTURE FROM THE DELIVERY HOSPITAL/CLINIC

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).