The two-year-old had received a transplant in December, reportedly with a heart that was damaged during transit by coming into direct contact with dry ice.

Prosecutors are investigating six medical staff.

“It’s over. Domenico’s gone,” the two-year-old’s mother Patrizia Mercolino told Italian media.

She said a foundation would be opened in his name.

Her son had been on life support for weeks at a hospital in Naples in a case that has made headlines in Italy.

The donor heart was reportedly transported from Bolzano in northern Italy to Naples – 800km away – in an unsuitable container without a thermometer that could have signalled the excessively low temperature.

Health minister Orazio Schillaci said in a statement quoted by Italian media that Domenico’s case had “moved the whole of Italy”.

Schillaci earlier spoke of his concern that organ donations could decrease as a result of the case, and called for “clarity” to ensure continued trust in the country’s medical services.