| Brasil et al, 2016[1] Nielsen-Saines et al, 2019[2] | Hoen et al, 2018[3] | Pomar et al, 2018[4] | Mulkey et al, 2019[5] Mulkey et al, 2020[6] | Ospina et al, 2020[7] | Coutinho et al, 2020[8] |
Site and recruitment period | - Rio de Janeiro, Brazil
- September 2015 to May 2016
| - French Guiana, Guadeloupe, and Martinique
- March 2016 to November 2016
| - French Guiana
- January 2016 to July 2016
| - Barranquilla, Colombia, and Washington, DC
- June 2016 to June 2017
| - Colombian national surveillance system
- June 2015 to July 2016
| - Ribeirão Preto, Brazil
- 2015 to 2016
|
Study design | | | | | | |
Inclusion criteria for pregnant women | - Symptomatic ZIKV infection with rash confirmed by RT-PCR of blood or urine (rash with onset ≤5 days)
| - Symptomatic ZIKV infection with at least one of the following confirmed by RT-PCR of blood or urine or both: rash, fever, conjunctivitis, arthralgia, or myalgia
| - Symptomatic or asymptomatic ZIKV infection confirmed by RT-PCR in blood or urine or ZIKV IgM
| - Symptomatic ZIKV infection with positive RT-PCR, IgM, IgG, or PRNT for ZIKV
| - Symptomatic ZIKV infection with positive RT-PCR in serum
| - Symptomatic ZIKV infection with positive RT-PCR of blood, urine, amniotic fluid, or placenta
|
Number of women with confirmed ZIKV infection in pregnancy | | | | | | |
Number of miscarriages/fetal losses | | | | | | |
Loss to follow-up before or immediately after birth or excluded participants | | | | | | |
Number of neonatal deaths | | | | | | |
Number of infants with follow-up | | | | | | |
Median infant follow-up time | - 18 months (range 7 to 32 months)
| | - 3 days of life (range 0 to 7 days)
| - 18 months (range 4 to 18 months)
| | - Birth (range 0 to 3 months)
|
Outcome measure | - Clinical abnormalities at birth and on follow-up
- Eye findings
- Hearing findings
- Neurodevelopment
| - Clinical findings on the day of birth
| - Clinical findings in the first week of life
| - Neuroimaging findings
- Neurodevelopment
| - Adverse pregnancy or neonatal outcome reported to surveillance system
| - Pregnancy losses
- Abnormalities at birth to 3 months of age
|
Microcephaly | | | - 31 (11.4%) of 273 infants
| | | |
Small for gestational age | | | - 26 (10.2%) of 255 infants
| | | |
Preterm infants | | | | | | |
Eye abnormalities on funduscopic examination | - 128 examined (59.3%) and 9 (7%) had abnormalities
| - 39 with neurologic findings (7%)
| | | | - 174 examined (35.6%) and 8 (4.6%) had abnormalities
|
Hearing abnormalities | - 101 assessed (46.8%) and 13 (12%) had abnormalities
| | | | | - 261 assessed (53.4%) and 1 (0.4%) had an abnormality
|
Below average neurodevelopment | - Of 216 children evaluated, 62 (28.7%) had below average neurodevelopment
| | | - In 70 children evaluated, decline in neurodevelopment scores noted over time, 33% with abnormal findings
| | |
Neurodevelopment tool | - Bayley-III
- Hammersmith Infant Neurological Examination
| | | - Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA)
- Alberta Infant Motor Scale (AIMS)
| | |