Continuous respiratory support to newborn infants
|Coordinator||Karolinska Universitetssjukhuset - Tema Barn och Kvinnosjukvård|
|Funding from Vinnova||SEK 793 004|
|Project duration||May 2019 - April 2021|
|Call||Medtech4Health: Support for Innovators in Care and Healthcare 2019|
Purpose and goal
The aim of the project is to acquire clinical experience of a new system for respiratory support of newborn infants and to evaluate a strategy for providing uninterrupted respiratory support during the first hours of life. The overall aim of the research is to develop strategies that support the infant’s breathing and reduce the need for mechanical ventilation.
Expected results and effects
We have developed a new respiratory support system that helps newborn infants to establish breathing. The new system allows uninterrupted support directly at birth and the next few hours. Our project aims to test the system in a clinical trial to evaluate ease of use and the feasibility of a strategy that provides uninterrupted support for the first hours of life. The new system has several advantages over existing devices and we believe that it will improve clinical management of newborn infants with breathing difficulties.
Planned approach and implementation
In summary the project plan includes: 1) development of a system for use in a clinical trial of newborn infants 2) plan and conduct the trial and 3) evaluate manufacturing and protection of the design. The largest part of the project will be related to planning and conducting a proof of concept (feasibility) trial in newborn premature infants. The study will start at Karolinska University Hospital after ethical review. Parents will be asked if they would like to participate before the infant is born.