In a major breakthrough, researchers from Italy have created the world’s first kidney dialysis machine that can be used to treat newborn babies and small infants. The machine has already seen success in treating a newborn baby who had multiple organ failure.

Prof. Claudio Ronco, of San Bortolo Hospital in Italy, and colleagues recently published the details of their creation in The Lancet.

Acute kidney injury, also known as kidney failure, affects around 18% of low-birthweight infants and approximately 20% of children admitted to intensive care.

For newborns who have kidney failure, peritoneal dialysis is the first port of call for treatment. This involves using a continuous renal replacement therapy (CRRT) machine to remove waste products from the blood through a catheter inserted into the abdomen.

However, the research team notes that in some cases the procedure is ineffective and unfeasible for infants that are so small. Current CRRT machines – although used off-label among infants smaller than 15 kg – have not been designed for neonatal use.

“A major problem is the potential for errors in ultrafiltration volumes. Adult dialysis equipment has a tendency to either withdraw too much fluid from a child, leading to dehydration and loss of blood pressure, or too little fluid, leading to high blood pressure and edema,” explains Prof. Ronco.

With this in mind, the researchers set out to create a new dialysis machine specifically for use in newborns and small infants.

The team developed the Cardio-Renal Pediatric Dialysis Emergency Machine (CARPEDIEM) – a miniaturized CRRT device that can provide kidney support for newborns and infants weighing between 2 kg and 10 kg.

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Pictured is the CARPEDIEM machine in action. The device successfully treated a 2.9-kg newborn with multiple organ failure.
Image credit: Claudio Ronco.

Compared with current CRRT machines, CARPEDIEM has the ability to process significantly low blood and ultrafiltration flows, and it also enables the use of a much smaller catheter, which the researchers say could prevent blood vessel damage.

To determine the effectiveness of the device, the team tested it on a 2.9-kg newborn baby girl in Italy who suffered multiple organ failure as a result of delivery complications.

After 30 days of using the device, the researchers found that the infant was able to breathe on her own, made sufficient amounts of urine and her organ function was restored. She was discharged from the hospital 20 days later, although she still had chronic kidney disease.

“Without a dedicated CRRT platform, renal replacement therapy would have been impossible because of technical and clinical contraindication to peritoneal dialysis and an inability to achieve reliable vascular access for the use of existing machines,” the researchers say. “We hypothesize an inevitable fatal outcome would have occurred a few days after birth without the use of the CARPEDIEM.”

Commenting on the success of the device, Prof. Ronco says:

We have shown how the technical challenges of providing CRRT can be overcome without relying on the adaptation of technology used in adult settings, and that a CRRT device designed specifically for use in neonates and small children can be used to safely and effectively treat acute kidney injury in small pediatric patients.

We hope that our success will encourage the development of other medical technologies (e.g., catheters, fluids and monitors) specifically designed for infants and small children.”

In an editorial linked to the study, Benjamin Laskin, of The Children’s Hospital of Philadelphia, and Bethany Foster, of the Montreal Children’s Hospital in Canada, note that initial results of CARPEDIEM are “encouraging.”

However, they say more research is needed to determine whether “adequate solute clearance can be achieved in all patients with the low blood-flow rates and reduced-volume filters of CARPEDIEM.”

Earlier this year, Medical News Today reported on a study published in the journal Biomaterials Science, which detailed the creation of a nanofiber mesh that could be a wearable and cheaper alternative to kidney dialysis.