The National Institutes of Health (NIH) announced $157 million in awards in fiscal year 2016 to launch a seven-year initiative called Environmental influences on Child Health Outcomes (ECHO). The ECHO programme will investigate how exposure to a range of environmental factors in early development — from conception through early childhood — influences the health of children and adolescents.
“Every baby should have the best opportunity to remain healthy and thrive throughout childhood,” said NIH Director Francis S. Collins, M.D., Ph.D. “ECHO will help us better understand the factors that contribute to optimal health in children.”
Experiences during sensitive developmental windows, including around the time of conception, later in pregnancy, and during infancy and early childhood, can have long-lasting effects on the health of children. These experiences encompass a broad range of exposures, from air pollution and chemicals in our neighbourhoods, to societal factors such as stress, to individual behaviours like sleep and diet. They may act through any number of biological processes, for example changes in the expression of genes or development of the immune system.
The awards announced will build the infrastructure and capacity for the ECHO programme to support multiple, synergistic longitudinal studies that extend and expand existing cohort studies of mothers and their children. ECHO research will focus on factors that may influence health outcomes around the time of birth as well as into later childhood and adolescence, including upper and lower airway health and development, obesity, and brain and nervous system development. A critical component of ECHO will be to use the NIH-funded Institutional Development Awards (IDeA) program to build state-of-the art paediatric clinical research networks in rural and medically underserved areas, so that children from these communities can participate in clinical trials.
“I’m very excited to work with many of our nation’s best scientists to tackle vital unanswered questions about child health and development,” said ECHO programme director Matthew W. Gillman, M.D. “I believe we have the right formula of cohorts, clinical trials and supporting resources, including a range of new tools and measures, to help figure out which factors may allow children to achieve the best health outcomes over their lifetimes.”
The ECHO infrastructure includes the following programmatic components:
Paediatric Cohorts: ECHO will fund existing paediatric cohorts with a goal of enrolling more than 50,000 children from diverse racial, geographic and socioeconomic backgrounds to become part of the ECHO consortium. These cohort studies will analyze existing data as well as follow the children over time to address the early environmental origins of at least one of ECHO’s health outcome areas. Each cohort will participate with the others to combine data that are collected in a standardized way across the consortium.
Coordinating Center: The ECHO Coordinating Center will be the central site responsible for organizing and managing activities and logistics for all collaborative components of the initiative, including oversight and coordination of the multi-cohort study design, evaluation of progress and tissue sample storage. The coordinating center will develop standard operating procedures for how each cohort collects core elements, including demographics, typical early health and development data, genetic influences, environmental exposures and patient reported outcomes. The ECHO Coordinating Center will include an Opportunities and Infrastructure Fund to support pilot projects, encourage junior investigators and introduce new tools and technologies in the context of the ECHO programme.
Data Analysis Center: The ECHO Data Analysis Center will be responsible for managing all existing and new data from ECHO paediatric cohorts. The center will develop and apply new analytic methods for combining and analyzing existing and new longitudinal data from participating cohorts collectively, and will conduct sophisticated multi-level analyses on pooled consortium data to pinpoint potential causes of child health outcomes over time.
Children’s Health and Exposure Analysis Resource (CHEAR) Core: The ECHO CHEAR Core will serve as a consortium resource for laboratory and statistical analyses of personal environmental exposures in existing and future collections of biological samples. It will build off the existing CHEAR resource.
Patient Reported Outcomes Core: Researchers in the ECHO Patient Reported Outcomes (PRO) Core will capture the voices and experiences of children and their families who are participating in the paediatric cohort consortium. The PRO Core is responsible for maintaining and providing PRO information for consortium researchers, assisting researchers with incorporating PROs into their study designs and coordinating methods for updating, validating and administering PRO information in studies.
Clinical Sites for the IDeA States Pediatric Clinical Trials Network: ECHO will leverage NIH-funded institutions that are part of the IDeA Program to build an IDeA States Pediatric Clinical Trials Network (ISPCTN). The goal of the ISPCTN is to provide medically underserved and rural populations with access to state-of-the-art clinical trials, apply findings from relevant paediatric cohort studies to children in IDeA state locations, and build paediatric research capacity at a national level. Funding will also support professional development of faculty-level paediatricians and their support teams in the conduct of clinical trials research.
Data Coordinating and Operations Center for the IDeA States Pediatric Clinical Trials Network: The center will be the central site within the ISPCTN that provides data coordination, technical instruction, data standards, quality control and assurance and operational coordination for IDeA States paediatric clinical trials. It also will serve as the ISPCTN liaison with other ECHO entities.