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Trial to examine effect of Zika in infants, young children infected postnatally
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A new trial funded by the NIH will examine the impact of Zika virus infection on early brain development in infants and young children in rural Guatemala who were infected after birth.
“This natural history study of Zika among Guatemalan children promises to yield valuable insights into acute and longer term outcomes of infection, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), said in a press release. “It is imperative that we understand the potential neurologic and neurodevelopmental outcomes of Zika virus infection in children infected in infancy and early childhood.”
The study, conducted by the NIAID and FUNSALUD, a nonprofit foundation in Guatemala, will include a cohort of approximately 300 infants and young children younger than 5 years of age who acquired Zika or dengue virus infection, or both. postnatally, as well as a cohort of 500 newborns without Zika virus infection and a sibling cohort of approximately 400 young children. Researchers will follow the participants for at least 1 year to compare the outcomes of Zika-infected participants with those of non-Zika-infected participants, all of whom will regularly undergo screening for potential new Zika, dengue and chikungunya virus infections, as well as regular examinations assessing for microcephaly, encephalitis, Guillain-Barré syndrome, seizures, neurodevelopmental delays, hearing loss, eye problems and other neurologic issues.
“[The study] will help provide access to the early diagnosis of Zika for families in this rural area of Guatemala, while helping us uncover whether this virus can interfere with the normal development of young children,” Antonio Bolaños, MD, medical director at the FUNSALUD clinic, said in the release. “For many impoverished children in our country, any Zika effect on their neurodevelopment will add burden to their futures.”
Researchers will also compare Zika-related outcomes with the outcomes of other viral infections, including dengue and chikungunya, and examine whether certain levels of Zika virus nucleic acid and neutralizing antibodies correlate with clinical, neurologic or neurodevelopmental outcomes. Secondary goals of the study include characterizing the effect of prior dengue infection among Zika-affected participants and their mothers on disease severity, as well as determining how long Zika RNA persists in children and maternal breast milk.
According to the NIH, the study will take 3 years to complete; however, preliminary results may be available in 1 year.
Disclosures: Fauci reports no relevant financial disclosures. Infectious Disease News was unable to confirm other relevant financial disclosures at the time of publication.