Health outcomes of children born/suspected with ZIKV: Protocol for the ZIKAction Paediatric Registry in Latin America and the Caribbean

Abstract

Background: Although the number of Zika virus (ZIKV) cases has substantially declined in Latin America and the Caribbean since the 2015-2016 outbreaks, the cohort of children born at that time and affected by congenital zika syndrome (CZS) are now around 4-5 years old and experiencing an ongoing impact on their health and development. Gaps in our understanding remain regarding the outcomes of ZIKV exposure in utero and congenital infection and the consequences of congenital zika syndrome (CZS) for health throughout childhood. Methods: The ZIKAction Paediatric Registry is an international multi-centre registry of infants and children with documented ZIKV exposure in utero (i.e. born to mother with confirmed infection in pregnancy) and/or with confirmed or suspected congenital ZIKV infection. Clinical teams at participating sites in Argentina, Brazil and Jamaica conduct retrospective case note reviews of children eligible for inclusion in the Registry and enter pseudonymised data into a central Registry database, with additional data collected prospectively on routine follow-up at some sites. Data collected will include sociodemographic, maternal and pregnancy information, delivery information and newborn assessment, paediatric clinical assessments (physical, neurological, developmental, ophthalmological, audiological), and laboratory results conducted as part of local standard of care. The ZIKAction Paediatric Registry network will conduct pooled analyses to address questions relating to characteristics, health and neurodevelopmental outcomes of this population. The Registry is embedded within a larger programme of research studies conducted by ZIKAction. Discussion: As the health outcomes of children affected by ZIKV continue to unfold, this paediatric registry will provide comprehensive data on their clinical and neurodevelopmental outcomes, growth and management, as well as on later sequelae. This will inform their support and care and provide potential insights on pathogenesis of the disease, of importance to currently affected families and for the response to possible future outbreaks. It will highlight the service needs of the affected populations in Latin America and the Caribbean and allow the identification of potential participants for future studies.

Dengue, chikungunya and zika arbovirus infections in Caribbean children

“…Phylogenetic studies confirmed the arrival of the zika virus (ZIKV) in Jamaica, the Dominican Republic and Haiti, over 9 months before the formal identification of the first clinical case [39,40 ▪▪ ]. Zika has penetrated the Caribbean region (Table 1) [25,39,40 ▪▪ ,41–50,51 ▪▪ ,52–54,55 ▪▪ ,56–65]. The link of zika to congenital zika syndrome (CZS) and Guillain–Barre syndrome (GBS) has been established in the Caribbean, along with other intrauterine pregnancy complications, febrile illnesses, and unusual neurological complications in children (Figs.…”

“…The link of zika to congenital zika syndrome (CZS) and Guillain–Barre syndrome (GBS) has been established in the Caribbean, along with other intrauterine pregnancy complications, febrile illnesses, and unusual neurological complications in children (Figs. 2(a–e) and 3(a and b)) [40 ▪▪ ,41–50,51 ▪▪ ,52–54,55 ▪▪ ,56–65]. In French Guiana, maternofoetal transmission occurred in 26%; among ZIKV-positive foetuses/newborns, 20% had moderate signs, 21% had severe signs of CZS and 14% had foetal loss [44].…”

“…2 a–e) [ 48 ]. The Jamaica cohort within the ZIKAction Pediatric Registry reported that 58.5% of children with suspected CZS had congenital microcephaly and 28.3% had severe microcephaly, between June 2016 and October 2019 [ 49 ]. Craniofacial disproportion was seen in 37.8%.…”

“…Jamaica has documented the usefulness of and adherence to a ZIKApp in pregnancy to identify arbovirus symptoms early in pregnancy to thereby facilitate early diagnosis of infections and maximize maternal care [ 72 ▪▪ ]. The ZIKAction research initiative continues to elucidate these arboviruses in pregnant women, infants and children in Jamaica and Haiti [ 16 , 18 ▪▪ , 19 , 31 ▪▪ , 32 , 43 , 48 , 49 , 57 , 58 , 61 – 65 , 72 ▪▪ ].…”

Perinatal characteristics and longer-term outcomes in Brazilian children with confirmed or suspected congenital Zika infection: ZIKAction Paediatric Registry

“…The multi-centre international ZIKAction Paediatric Registry is a disease/exposure hospitalbased paediatric registry, the protocol of which has been published; specific objectives were to describe the clinical features, neurodevelopmental characteristics and growth of included J o u r n a l P r e -p r o o f children, to assess their long-term sequelae and management and to provide a platform for future studies. 13 The Registry was established in Brazil (in Bahia state), in Argentina (in Buenos Aires) and in Jamaica (national). This analysis is restricted to the retrospective data collected within the ZIKAction Registry in Bahia by July 2021.…”