This prospective cohort study enrolled a total of 1,371 subjects,
including 500 infants, from June 2017-July 2018, and followed them for
one year to determine the incidence of postnatal Zika infection and its possible association with neurodevelopmental delay. The final study visits were in July 2019, with 1,127 subjects completing all study procedures (82%), and most dropouts occurring within the first two months of the study, a great cohort retention rate in this challenging setting. The study captured a total of 407 flavivirus-like illnesses from 289 subjects. Dengue, Zika and Chikungunya testing is underway.
The most significant finding is the severe neurodevelopmental delays
for all ages. The Mullen (MSEL) neurodevelopment scores The mean MSEL
scores in Guatemala were around 2SD below the US (<5th %ile). This
tool has a mean score of 100 (composite) and 50 (each of the 5
subdomains) in US children. These incredible delays finally put a number on a phenomenon that we’ve been observing for a long time at the site.
Multiple analyses are ongoing to better understand the predictive factors, though malnutrition likely plays a significant role: 37% of the
children in the study suffered from stunting, and this was
significantly associated with neurodevelopmental delay (p=0.0039). We
also found that 17% of the children had microcephaly (an extremely high
incidence not seen in other countries, confirming our previous data,
which was also strongly associated with neurodevelopmental delay