Abstract
BackgroundWhile microcephaly is a significant adverse outcome of prenatal exposure to the Zika virus (ZIKV), subtle malformations of cortical development (MCD) have been observed in Zika-exposed children (ZEC), including delays in language, cognition, and motor domains, and visual acuity deficits. Interventions within the first 1,000 days of life can significantly improve developmental outcomes. This study examined a 12-week Responsive Caregiving Intervention on neurodevelopmental outcomes in 24-30-month-old ZEC.Methodology/Principal findingsA randomized controlled trial was implemented in Grenada, West Indies using an existing ZIKV cohort surveillance study. When children in that study turned 24 months, baseline child neurodevelopmental measures and caregiver interviews were administered. Caregivers who agreed to participate in the 12-week Responsive Caregiving Intervention, implemented when children were 24–30 months of age, were randomly assigned to the Intervention or Waitlist Control group. Children in both groups were re-assessed on the neurodevelopmental measures post-intervention.Conclusions/Significance233 children from the ZIKV surveillance study met inclusion criteria, of which n = 80 declined participation, n = 42 did not complete the Intervention, and n = 72 missed follow-up assessments given strict timelines in the study design. The final sample for analysis was N = 13 children in the Intervention group and N = 26 children in the Control group. A GEE model analysis showed significantly higher language (p = 0.021) and positive behaviour (p = 0.005) scores for children in the Intervention group compared to the Control group. The Intervention had a medium effect on child language (d = 0.66) and a large effect on positive behaviour (d = 0.83). A 12-week Responsive Caregiving Intervention Programme significantly improves language and positive behaviour scores in 30-month-old normocephalic children who were exposed to ZIKV in utero. The programme provides an option for mothers of ZIKV-exposed children who are seeking an evidence-based neurodevelopmental intervention regardless of known impact of the virus on cortical formation.Trial registrationThe study was registered with clinicaltrials.gov (NCT04697147).
Highlights
On 1 February 2016, the World Health Organization (WHO) declared a Public Health Emergency of International Concern (PHEIC) regarding microcephaly and other neurological disorders associated with the Zika virus (ZIKV)
The present study utilized a randomized controlled trial to examine the impact of a 12-week Intervention on neurodevelopmental outcomes in 24-30-month-old Zika-exposed children
The application of interventions from the global early child development field has implications for governments, policy makers, public health officials, and parents of Zika-exposed children who are seeking effective interventions to mitigate the risk of neurodevelopment delays in those children
Summary
On 1 February 2016, the World Health Organization (WHO) declared a Public Health Emergency of International Concern (PHEIC) regarding microcephaly and other neurological disorders associated with the Zika virus (ZIKV). While the PHEIC was lifted on 18 November 2016, the WHO still considers the Zika epidemic and the associated complications a significant public health challenge requiring intense action, [1], and a global consortium has been established to examine pooled data from ZIKV infection [2]. Zika is a vector-borne virus spread via the bite of an infected Aedes spp. mosquito. It was first identified in Uganda in monkeys in 1947 and later in humans in 1952 [3]. While existing data suggests that no cases have been reported in the Caribbean region since December 2016 [6], studies continue to examine the potential impact of infection on children born during the 2016 outbreak under the auspices of the original PHEIC. This study examined a 12-week Responsive Caregiving Intervention on neurodevelopmental outcomes in 24-30-month-old ZEC
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