Neurosurgeons from Alder Hey Children’s Hospital and The Walton Centre will be the chief investigators for the study, which has recently been awarded a £2m grant from the NIHR HTA* programme.
Hydrocephalus is a build-up of cerebrospinal fluid (the fluid which carries nutrients to the brain) in the brain. This excess fluid puts increased pressure on the brain, causing damage to brain tissue. The condition affects one in every 500 births and is one of the most common developmental disabilities in children. It also affects older children and adults and can be related to a variety of causes, including trauma, brain tumours, haemorrhage and infection.
The most common treatment for hydrocephalus is to insert a shunt into the brain to drain the excess fluid into the abdominal cavity. However, some of these patients later become seriously ill from infections related to the shunt insertion.
Infections have a significant impact on patients and the NHS with prolonged hospitalisation, additional surgery and possible intravenous and intrathecal antibiotics. There is also a risk of damage to the brain which can lead to reduced cognitive function and which can seriously affect the patient’s outcome.
The research study is being led by neurosurgeons Conor Mallucci and Michael Jenkinson. Both treat hundreds of patients each year with hydrocephalus and have already published extensively in this research area.
Mr Mallucci, Consultant Neurosurgeon at Alder Hey explains: “Insertion of a shunt for hydrocephalous is now one of the most common procedures performed in neurological units with between 3000 and 3500 shunt operations carried out each year. Ever since shunts started to be used in the 1950s, shunt infection has remained a significant problem.
“This study could have a huge impact on the outcomes of patients with hydrocephalous. It will investigate whether shunts coated in various agents can reduce the risk of infection. The research will involve comparing the use of three different types of shunts; a standard uncoated silicone shunt, a silicone shunt coated with antibiotics and a silicone shunt coated with silver.”
Mr Jenkinson, Consultant Neurosurgeon at the Walton Centre continues; “The study will involve a randomised controlled trial to determine whether the shunts coated with antibiotics or silver reduce infection, compared to the standard uncoated type.
“It will also provide an opportunity to study which organisms infect the different types of shunt and to investigate newer laboratory techniques such as proteomics and metabolomis to diagnoses shunt infection.
“Our hope is that this research will lead to a reduction in shunt infections suffered by children and adults. Such infections add to the burden of suffering with hydrocephalus, and we want to try and improve the care of patients so they can avoid this additional discomfort and stress.”
The trial was designed with clinical trialists at the University of Liverpool Medicines for Children Research Network Clinical Trials Unit (MCRN CTU). Trial coordination will be led by the MCRN CTU and supported by the NIHR Clinical Research Network. It will involve recruitment of patients across paediatric and adult regional neurosurgery units in the UK and Ireland. The MCRN and SHINE (Spina Bifida, Hydrocephalus, Information, Networking, Equality) have been approached to assist in identifying appropriate individuals to provide patient and public representation as members of the trial team.
Dr Carrol Gamble, Deputy Director of the MCRN CTU, says: “The University of Liverpool is committed to increasing the quality of the evidence base underpinning healthcare for children. We have developed expertise in designing and conducting clinical trials involving children, which will contribute to the successful delivery of this important trial.”
A six month pilot of the trial is set to begin in December at four centres in the country with 15 centres eventually taking part.
Source: www.alderhey.com
Spina bifida • Hydrocephalus • Information • Networking • Equality – SHINE
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