Continuous respiratory support to newborn infants
| Reference number | |
| Coordinator | Region Stockholm - Tema Barn och Kvinnosjukvård |
| Funding from Vinnova | SEK 793 004 |
| Project duration | May 2019 - August 2021 |
| Status | Completed |
| Venture | Medtech4Health innovators |
Purpose and goal
The aim of the project was to investigate and develop a system that can provide uninterrupted respiratory suport to infants children the first hours of life. The project also included investigating patents and a strategy for manufacturing.
Expected results and effects
After ethical review our clinical pilot study has been started and 22 premature infants have been recruited. We have not had any problems with safety and the new system has worked as intended. We have been able to provide respiratory support directly at birth and the first hours of life. A patent has been filed and we have investigated strategies for manufacturing of the system.
Planned approach and implementation
The project has been conducted as planned. The research group has experience from clinical studies and have not had any major problems with administration before starting and conducting the pilot trial. Recruitment has been faster than expected and more than half of the patients treated. The patent application has been filed and a strategy for manufacturing has been investigated. The new MDR has created uncertainties when in discussing costs and risks, as the experience of the new regulatory procedures are limited.