Study to focus on factors influencing brain development in kids with congenital heart disease

Some babies born with certain types of congenital heart disease have limited blood flow to their lungs and need an early procedure to help their hearts function properly.

Doctors and families may choose between surgery to place a shunt or a catheter-based approach to keep a small vessel called the ductus arteriosus open, allowing blood to reach the lungs.

While these procedures are lifesaving, children with these conditions remain at higher risk for challenges in brain development – and it’s unclear whether one type of procedure carries more risk than the other.

Now, a multicenter study aims to better understand those differences.

“The causes of neurodevelopmental abnormalities have been understudied for these children,” said Caren Goldberg, M.D., M.S., pediatric cardiologist at University of Michigan Health C.S. Mott Children's Hospital and co-investigator of the study.

“Our research aims to deepen understanding so we can improve outcomes for these patients.”

Researchers to evaluate neurodevelopment in two groups

The five-year CAN-DO study, which includes more than 20 pediatric heart centers and 300 pediatric heart patients across the United States, will evaluate neurodevelopment in two groups of children.

This will include one group who receives neonatal cardiac surgery and another who gets catheter-based interventions during the first month of life to address their congenital heart condition with ductal dependent pulmonary blood flow.

When we evaluate which approach is better for each patient we have historically only considered survival and morbidity rates. We now know that we should also be considering neurodevelopmental outcomes when we select treatment approaches.”

-Caren Goldberg, M.D., M.S.   

Researchers will compare neurodevelopmental differences between the two groups and also study how a baby’s environment, proteins, genes, and certain blood markers from infancy help predict their brain development.

“We know that babies who undergo heart surgery in their first year of life are at high risk for neurodevelopmental delays that affect behavioral and cognitive abilities,” Goldberg said.

“The goal of this research is to understand the factors, including the intervention type during the newborn period, that influence development and behavior for children born with heart problems requiring either a surgical shunt placement or placement through catheterization of a stent to keep blood flowing to the lungs.”

Evaluating neurodevelopmental milestones

Because babies born with complex heart conditions requiring cardiac interventions in the first year of life are at increased risk of neurodevelopmental impairments, experts recommend regular developmental checkups.

This helps identify concerns about learning, movement or behavior early. When issues are found, children can be connected with therapies and supports to help them with learning and development.

As part of the CAN-DO study, participating children will receive two developmental evaluations — one at 18 months and another at three years of age.

Assessments of neurodevelopment at 18 and 36 months are proactive and help to catch issues early, Goldberg says, in order to recommend appropriate interventions such as physical therapy, speech therapy or occupational therapy if needed.

“Our centers all jointly realized over the last 10-15 years that we need to evaluate children with critical heart disease for impairments that may show up later in life,” Goldberg said.

The research builds off the COMPASS trial, another large-scale study co-led by Michigan Medicine that harnesses data from Cardiac Networks United and the Pediatric Heart Network.

The COMPASS study also compares surgical and catheter-based interventions.

The new study will also utilize resources from the Congenital Cardiac Research Collaborative whose data coordinating center is housed at Michigan Medicine.

“When we evaluate which approach is better for each patient we have historically only considered survival and morbidity rates. We now know that we should also be considering neurodevelopmental outcomes when we select treatment approaches,” Goldberg said.

“Our priority is for all of our patients with congenital heart disease to live the healthiest lives possible and that includes not only physical health but functional health and the ability to thrive in other aspects of their lives.”

Additional authors: Kelly Wolfe, Ph.D., of Children’s Hospital of Colorado, is the principal investigator. Mark Russell, M.D., a professor of pediatric cardiology at Mott and the U-M Medical School is also a co-investigator.

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