The ECHO Program is excited to share that all 17 existing clinical sites within the IDeA States Pediatric Clinical Trials Network (ISPCTN), along with the Data Coordinating and Operations Center (DCOC), will continue to the Network’s second cycle. In addition, the Network is adding one clinical site, South Dakota Pediatric Clinical Trials Network, led by MPIs Dr. Amy Elliott and Dr. Katherine Wang.
The purposes of the ISPCTN are 1) to conduct clinical trials among children from rural or underserved populations, and 2) to build pediatric research capacity in historically low-resource institutions to conduct these trials. In this next cycle, ISPCTN will continue its four ongoing trials, including two trials to address care of newborns exposed to opioids in utero. The Network will also stand up at least three new trials. Opportunities to address the COVID-19 pandemic are of particular interest. Learn more about two of the ISPCTN’s current trials below.
IDeA States Pediatric Trials Network Update on VDORA and iAmHealthy
Infants and children living in rural parts of the United States are less likely than children in urban centers to have a chance to enroll in clinical trials. In 2016, the NIH started the ISPCTN to bring research to children in rural and underserved parts of the country. This group of pediatric researchers from 18 states is working to make sure that children in states with historically low funding for research have access to clinical trials as part of ECHO.
Asthma is one of the most common illnesses in children and impacts families across the country. Children with higher body mass index or BMI can have more severe asthma symptoms than other asthmatic children with lower BMI. Vitamin D is a vitamin that helps many parts of the body, including bones and the immune system. Because vitamin D is stored in fat, doctors do not currently know the ideal amount of vitamin D that children with higher levels of body fat and a BMI greater than or equal to 85% for their age and sex, should take in order to get the most health benefits. Vitamin D Oral Replacement in Asthma (VDORA) is a study that ECHO ISPCTN is currently running to begin to answer this question.
The focus of the VDORA1 study is to help determine what dose of vitamin D would work best for children with higher BMI than other children their age with asthma, and low vitamin D levels in their blood. The children in the study will take vitamin D at different doses and have their blood-levels of vitamin D measured at regular times. The study team will also ask about asthma symptoms, to see if these symptoms change while the child is taking vitamin D. Over 70 children have participated in this study so far and the study will continue through spring 2021.
Childhood obesity is an increasing problem throughout the country and is an important outcome that the ECHO Program studies. It can be hard for families in rural areas to work with health care providers to learn healthy food and activity habits. Over 100 children and their families from four states are now participating in the iAmHealthy feasibility study. This is a 6-month trial, studying the best ways to teach children who live in rural areas how to eat and exercise daily to create a healthier mind and body. Half of the children and families will receive a monthly newsletter in the mail with healthy diet, activity, and lifestyle tips. The other half will have individual and group sessions with health care coaches via video conferences.
Importantly, this trial is also studying the best ways to recruit children and families into research studies, which may be harder in rural and other areas with little research experience. The study is being done virtually without any face-to-face visits required, using electronic communication for consenting, measuring height, weight, and activity, and delivering all the other parts of the study. The lessons learned about research in rural areas and without face-to-face visits will help other studies reach a larger number of children.