Researchers at All Children's Hospital Johns Hopkins Medicine in St. Petersburg, Florida launched a ground-breaking Institution-wide Prospective Inception Cohort Study (iPICS) in 2013 designed to identify key predictors of outcome in children with a variety of acute and chronic health conditions.
Now comes the sequel: PREDICT, which is perhaps really the prequel to iPICS.
While iPICS looks for factors that affect the progress and outcome in children who already have a specific health problem, PREDICT (Prospective Research on Early Determinants of Illness and Children's Health Trajectories) seeks to learn why some children-healthy at birth and in early childhood-go on to develop health problems. Both studies are part of an important new shift in pediatric medicine toward population health with a focus on preventing and managing disease to promote long-term health.
PREDICT will follow groups of infants and young children to look for factors that influence development and health of the brain and body, with a special focus on obesity later in childhood and adolescence, poor neurodevelopment and other conditions. Like iPICS, the study takes advantage of the new Johns Hopkins Medicine Pediatric Biorepository at All Children's Hospital. Small samples of blood and saliva from the healthy infants and children will be stored in the robotic biorepository. Clinical and patient-reported outcomes collected through long-term follow-up will be linked to the sample data to search for prognostic biomarkers and other key factors.
"The rationale for PREDICT is the need, and opportunity, to unravel the mysteries of how some kids ultimately stay quite healthy in their journey to adulthood, while others fall off that trajectory," says Sara Johnson, Ph.D., M.P.H., assistant professor of general pediatrics and adolescent medicine at Johns Hopkins University. "We want to understand what's different about the kids who go on to develop chronic conditions like obesity and poor neurodevelopment that can impact health for many years-and find the risk factors that differentiate them from children who don't develop these health problems."
The best way to do that is to study children before they develop chronic conditions-before they become obese or before their neurodevelopment begins to "fall off the curve."
"Identifying these risk factors will point us toward intervention and prevention, with the ultimate goal being to improve the health of communities and the productivity of the next generation of adults," explains Neil Goldenberg, M.D., Ph.D., associate professor of pediatrics and director of research at All Children's Hospital Johns Hopkins Medicine. He and Johnson are co-principal investigators for PREDICT. "We're excited to start from the beginning, looking for risk factors that are hidden or not yet identified, including prenatal risk factors."
To do that, a team of research nurses will help the investigators create a birth cohort by enrolling pregnant women and a separate early childhood cohort that includes kids up to age 6, explains Frances Hamblin, R.N., C.C.R.P., director of research operations at ACH JHM and senior project manager for iPICS and PREDICT. Both cohorts will be followed long-term to provide a wealth of information for analysis.
Child psychologist Eric Storch, Ph.D., is a PREDICT co-investigator, sharing his clinical and research expertise in neuropsychiatric disorders, developmental delay and disabilities like autism. "We're collecting a number of variables that cross molecular, genetic, clinical, social and behavioral domains to start understanding the interplay between all these variables, with the overall goal of improving our ability to intervene successfully and shift the curve toward better, healthier outcomes," he says. This approach could yield important information to help children who are developmentally delayed and those who are not making appropriate gains in academics or other areas of cognitive functioning.
Storch, who holds the All Children's Hospital Guild Endowed Chair in Neurodevelopment at the University of South Florida Morsani College of Medicine and also serves as director of research for developmental pediatrics at All Children's Hospital, notes that PREDICT is a great opportunity for clinicians and researchers at Johns Hopkins, All Children's Hospital, the University of South Florida and other centers in the region to build on their shared passion and discover new ways to improve children's physical and intellectual development."
Another key focus for the birth cohort is to look at physical development as it relates to obesity, which remains an urgent public health priority.
To explore prenatal factors that may predispose children to obesity, St. Petersburg-based obstetrician-gynecologist Sheila Devanesen, M.D., will share and build upon her ongoing research for an All Children's Hospital study, Fit4AllMoms, which investigates how exercise, nutritional and educational interventions during pregnancy in obese women affect perinatal outcomes for mothers and babies.
"When you consider the numerous biochemical proteins that circulate between a mother and her developing fetus, coupled with the rise of childhood obesity at a very early age, my goal with Fit4AllMoms and now with PREDICT is to help identify factors that may be at work even in utero that contribute to our metabolic picture into adulthood," says Devanesan.
Co-investigator Raquel Hernandez, M.D., M.P.H., is already active in childhood obesity research and is piloting a clinic at All Children's for overweight and obese children. An assistant professor of pediatrics at Johns Hopkins University and the associate director of medical education at All Children's Hospital Johns Hopkins Medicine, Hernandez is working with Goldenberg to develop an obesity cohort for iPICS to parallel the PREDICT cohort. "The idea is that we will continue to provide great clinical care while moving ahead with our research to link risk factors with outcomes, following patients through life."
Co-investigator Rachel Thornton, M.D., Ph.D., assistant professor of pediatrics at Johns Hopkins University and a 2010 White House fellow, studies the link between childhood obesity and risk for cardiovascular disease, and will explore how a child's family or neighborhood environment factors into the equation. "One of the great things about PREDICT is the opportunity to build a cohort of children who start off healthy and observe over time how different types of exposures influence their health, including their risk of obesity and their long-term risk for heart disease and hypertension."
Constructing the Cohorts
Beyond the hallways of the hospital and clinics, PREDICT requires a broader group of study participants. Thornton is tackling this challenge, speaking with community leaders, organizations and neighborhoods about the study's importance. It will require collaboration among researchers, pediatricians, hospitals and community organizations to get plenty of children to participate.
"People who have healthy young kids may not perceive a benefit to being part of 'medical research,'" she says. "When a child has a specific disease, families often are motivated to enroll in a study that could help their child and others with the same disease. With PREDICT, our task is to clearly convey the potential long-term benefits to all the children in our communities."
Integration and Innovation
The two research programs represent significant milestones in the integration of All Children's Hospital with Johns Hopkins Medicine. They reflect the shared vision of All Children's Hospital president and physician in chief Jonathan Ellen, M.D., and Johns Hopkins Children's Center director George Dover, M.D., to promote collaboration and innovation in treatment, education and research at the two hospitals and foster new approaches to population health. The All Children's Hospital Foundation helps make that vision a reality with an institutional research grant to fund the launch and the first three years of PREDICT.
"The PREDICT program is a bold and crucial step in our research mission - one that can help us gain vital insights into how diseases develop in children," says Ellen, professor of pediatrics and vice dean for All Children's Hospital at the Johns Hopkins University School of Medicine. "As we embrace a population health approach, these programs can have a profound impact in understanding how children become sick, and how we can prevent certain conditions and keep children well."