U.S. ZIKA PREGNANCY AND INFANT REGISTRY (USZPIR)/M2, (NOFO) #CK14-1401PPHF14 PROJECT M2

Eunice Kennedy Shriver National Institute Of Child Health & Human Development

Investigators

Abstract

Background CDC transitioned its emergency response to the Zika virus outbreak in the United States to normal program operations on September 29, 2017. While the threat of a widespread Zika virus outbreak in the U.S. has diminished, a sustained response with dedicated resources for infants and children affected by congenital Zika virus infection and its associated neurological complications remains a public health priority. The U.S. Zika pregnancy/ Maternal Health and infant registry (USZPIR) project has provided jurisdictions financial and technical support for collaborative participation in the USZPIR for completion of follow up of pregnant women and the exposed fetuses, infants, and children in the USZPIR since August 2016. Complete follow up of the infants and children in the Zika Pregnancy or Maternal Health and Infant Registry is essential to monitor the full impact of congenital Zika virus infection. Purpose This agreement between the Centers for Disease Control and Prevention and two institutes within the NIH, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institute of Allergy and Infectious Disease (NIAID) will promote collaboration and provide support to the USZPIR for ongoing monitoring of long-term effects of congenital Zika virus exposure on infants and children under the Notice of Funding Opportunity (NOFO) #CK14-1401PPHD14 Project M2, ?Building domestic surveillance, laboratory, vector control and pregnancy registry capacity to respond to Zika virus.? maternal health Through this intra-department delegation authority (IDDA), USZPIR will be awarded supplemental funding from NICHD and from NIAID for the Year 3 budget period of performance 8/1/2018 ? 7/31/2019. Description of Work Since January 2018, the primary goal of the USZPIR is to monitor and inform the response to long-term effects of congenital Zika virus exposure on infants and children. While the association between Zika virus infection and congenital microcephaly and other central nervous system birth defects has been demonstrated, there is continued need to monitor long-term effects and the full range of disabilities to fully characterize the scope and impact of the outbreak and inform programs and services, including clinical management of congenital Zika syndrome. For the Year 3 Continuation (8/1/2018 ? 7/31/2019), CDC plans to award a limited number of jurisdictions based on (1) the number of cases reported to the USZPIR and (2) the availability and timeliness of complete data on infant outcomes. The jurisdictions are expected to produce the following outcomes: ? Improve epidemiological capacity to monitor pregnant women, infants, and children, who meet the USZPIR case definition. ? Improve completeness and timeliness of reporting of USZPIR data (including all data on the USZPIR surveillance forms where reporting is allowable by state laws/regulations) to state health departments and CDC in alignment with CDC established timeliness ? Improve follow up of pregnant women with laboratory evidence of possible Zika virus infection and their infants to assess fetal, birth, infant, and child outcomes. ? Improve monitoring of infants and children with laboratory evidence of possible Zika virus infection to assess long term health outcomes, with follow up to at least 24 months. ? Translation of public health data in real time into clinical and public health recommendations, particularly in the realm of early detection of development delays in infants. NIH will make funding available through an IDDA for the USZPIR year 3 budget to CDC. Coordinate with CDC on monitoring the scientific progress of pregnant women, infants, and children affected by congenital Zika virus infection.