Table 1 Data collection details

 Demographic Survey

Study entry

Basic demographics, e.g., age, race and ethnicity, marital status, and education

 Medical History

Study entry

History of: significant medical disorders; previous DENV or Yellow Fever infections and vaccination; any prior infections with parvovirus, herpes, cytomegalovirus, and syphilis

 Physical examination and Zika-like symptoms questionnaire

All visits

Assessment of general appearance, including height and weight, and blood pressure and temperature; history of recent symptoms consistent with ZIKV infections, including rash, fever, arthralgias, eye pain, and conjunctivitis

 Pregnancy questionnaire

Monthly visits

Signs/ symptoms of pregnancy complications, including decrease in fetal movement, rupture of membranes, vaginal bleeding, headaches, scotomata, nausea, and vomiting.

 Imaging assessments

Once per trimester

Ultrasound results

 Environmental/ occupational exposure survey

Once per trimester

Participant’s and her domestic partner’s occupational history; household characteristics; behavioral risk factors (e.g. drinking, smoking); exposure to animals in the home; and exposure to known environmental chemicals

 Delivery (live birth or fetal loss) information

At delivery

Mode, location, and outcome of the delivery

 Physical examination and growth parameters

All visits

Examination of cardiac, respiratory, and other systems, and skin and gastrointestinal conditions; weight, length or height, and head circumference; gestational age at birth and Apgar scores (birth visit only)

 Hearing, ophthalmologic, and neurological assessments

All visits

General motor development markers, including lethargy, seizures, reflexes, etc.; hearing assessments (otoacoustic emission or automated auditory brainstem response); general eye exams; and ophthalmologic exams to detect chorioretinitis or abnormalities in conjunctiva, lens, or retina. If initial exams are abnormal, infants will be referred for additional audiology and/or ophthalmology testing, and results (if available) from any tests done for clinical reasons will be recorded.

 Imaging studies

As done per local standard of care

Any imaging assessments done for clinical care, including any neuroimaging studies (ultrasound, CT, or MRI) obtained for clinical reasons to detect neurologic abnormalities such as intracranial calcifications.

 Neurodevelopmental assessment

3, 6, and 12- month visits

Screening neurodevelopmental assessments (Ages and Stages Questionnaire or the Bayley Infant Neurodevelopmental Screener) of all study participants. If results of screening assessment are abnormal, the infant will be referred for diagnostic neurodevelopmental testing using the Bayley Scales of Infant and Toddler Development (BSID) -III.