Danielle Soranno, MD, a pediatric nephrologist at Riley Children’s Health, is leading research to help provide life-saving peritoneal dialysis for neonates with acute kidney injury (AKI) in low- and middle-income countries.
The research team’s goal is to design and prototype a reliable, safe neonatal peritoneal dialysis catheter that can be placed by physicians at the bedside in countries across the globe where therapies such as neonatal hemodialysis are not available.
With AKI occurring in approximately 40% of critically ill neonates, the need is great, and the research is timely. Due to regulatory changes two years ago, there currently isn’t a peritoneal dialysis catheter approved for bedside placement in neonates. As a result, clinicians in lower-resourced countries are forced to improvise with various catheters that are not designed for peritoneal dialysis and not sized for pediatric use. These off-label devices are prone to leaking and occlusion, and they are often too costly for families in low-income countries to afford.
"Despite the best efforts and expertise of local clinicians, babies whose kidneys would likely recover with just five to seven days of peritoneal dialysis are dying due to the lack of a safe and affordable peritoneal dialysis catheter,” said Dr. Soranno. “We want to fill this unmet need with an effective, high-functioning catheter that’s approved for this use, affordable for families and meets regulatory requirements in the U.S. and Europe."
With a degree in biomedical engineering and expertise in polymer biomaterials, Dr. Soranno is a key member of the research team, which includes catheter design expert Hyowon Lee, PhD, a biomedical engineering professor at Purdue University, and Aaron Lottes, PhD, professor of engineering practice at Purdue, who has experience in regulatory science for medical products. The collaborators received funding from the Engineering in Medicine pilot program for the first year of their research. Currently, the team is using computational fluid dynamic modeling to better understand the impact of pore geometry and numbers. Prototypes with optimized features will then be fabricated, followed by benchtop flow evaluation to demonstrate that the device meets flow requirements.
The research is being conducted in collaboration with Professor Mignon McCulloch, pediatric nephrology chief at the Red Cross War Memorial Children’s Hospital in Cape Town, South Africa. Professor McCulloch has spent the past 25 years expanding pediatric dialysis globally. She trains clinicians around the world on how to perform peritoneal dialysis in children.
“As this work is my passion, I am thrilled to see the current momentum and progress toward realizing a new device that will meet the needs of our underserved pediatric patients,” said Professor McCulloch.
In year two, the team will conduct clinical feasibility testing of a prototype catheter and devise regulatory approval. Overall, the goal is to produce a catheter that’s ready for industry partners to move forward with final testing and regulatory submissions so the device can be brought to market to improve patient care.
“The catheter we’re working on will improve on prior designs to meet the needs of critically ill infants with AKI in these countries,” Dr. Soranno said. “Beyond this, an approved peritoneal dialysis catheter will also benefit babies worldwide in increasing the scope of acute dialysis options for kidney replacement therapy.”
Related Programs & Departments
Pediatric nephrologists at Riley Children’s are leaders in using novel technologies and research breakthroughs to launch new clinical programs that lead to better treatments for children impacted by kidney disease. With the only pediatric dialysis unit serving children in Indiana, Riley Children’s provides inpatient and acute hemodialysis and peritoneal dialysis services.
