Concord Neonatal achieves CE mark for the Concord Birth Trolley

Leiden, 4 September 2019 – Today Concord Neonatal is delivering brand-new Concord Birth Trolley’s to a number of Dutch hospitals, after achieving the CE mark yesterday. With the Concord Birth Trolley, Concord Neonatal enables hospitals to improve birth for all babies who need extra support, to provide lifesaving care with the umbilical cord intact, until the baby is fully stable and breathing on its own. Close to the mother, the baby gets maximum benefit from the blood from the placenta, up to the moment it is breathing on its own

A shock free birth for every baby
Around 1 in 10 babies has problems at birth. This affects over 35,000 newborn babies worldwide, every day. Scientific research shows that clamping the umbilical cord before a baby is breathing, causes a “shock” in the baby’s blood flow; a dangerous drop in heart rate and blood oxygen levels, increasing the risk of injury to its organs, especially the brains and intestines

Scientists Prof. Arjan te Pas and Prof. Stuart Hooper developed a new concept of care to give all babies a shock free birth, called Physiological-Based Cord Clamping: Clamping the umbilical cord at a time when the baby is fully stable and breathing on its own. This leads to a gentle switch from the oxygen rich blood flow from the placenta to autonomous breathing and blood flow. Physiological-Based Cord Clamping has the potential to reduce complications at birth, prevent long term disability and may even prevent loss of life.

Bringing science to clinical practice
The first ideas to develop a solution started in 2015, by a multidisciplinary team from Leiden University Medical Center. To allow wider implementation and multicenter clinical research, Concord Neonatal B.V. was founded in 2017 as a spin-off from LUMC. During the past 1.5 years, Concord Neonatal worked closely with VDL Wientjes Roden to develop the Concord Birth Trolley, which today successfully resulted in the delivery of the first brand-new Concord Birth Trolley’s including CE mark.

 

With the availability of the Concord Birth Trolley, Concord Neonatal started implementation of the Concord Birth Flow in all Dutch and international hospitals that are participating in the ABC-3 trial, a multicenter randomized trial led by LUMC, to research the benefits of Physiological-Based Cord Clamping. With the availability of the CE mark, Concord Neonatal can now start to scale-up and grow internationally, to eventually help all babies and their parents, across the world, to win in the first minutes of life