Skip to main content

Table 1 Data collection details

From: International prospective observational cohort study of Zika in infants and pregnancy (ZIP study): study protocol

AssessmentTime frameData collected
Maternal Data
 Demographic SurveyStudy entryBasic demographics, e.g., age, race and ethnicity, marital status, and education
 Medical HistoryStudy entryHistory 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 questionnaireAll visitsAssessment 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 questionnaireMonthly visitsSigns/ symptoms of pregnancy complications, including decrease in fetal movement, rupture of membranes, vaginal bleeding, headaches, scotomata, nausea, and vomiting.
 Imaging assessmentsOnce per trimesterUltrasound results
 Environmental/ occupational exposure surveyOnce per trimesterParticipant’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) informationAt deliveryMode, location, and outcome of the delivery
Infant Data
 Physical examination and growth parametersAll visitsExamination 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 assessmentsAll visitsGeneral 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 studiesAs done per local standard of careAny 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 assessment3, 6, and 12- month visitsScreening 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.