ENLIVEN-UK
Research type
Research Study
Full title
Endoscopic Lavage after Intraventricular Haemorrhage in Neonates in the UK: A national randomised controlled trial on the efficacy of neuro-endoscopic lavage
IRAS ID
322127
Contact name
Kristian Aquilina
Contact email
Sponsor organisation
University College London
Duration of Study in the UK
5 years, 1 months, 28 days
Research summary
Around one in thirteen infants is born preterm in the United Kingdom. Despite major advances in survival, intraventricular haemorrhage (IVH) remains one of the most serious complications of preterm birth. Intraventricular haemorrhage (IVH) is bleeding into the fluid spaces of the brain and is common in babies who are born premature. This results in a build-up of brain fluid, that may increase the pressure in the brain. Bleeding in the brain can cause a risk to life and also cause problems with vision, hearing, cognition (understanding) and motor function (movement).
Early and effective management in is therefore important to improving long-term outcomes, both of which are extremely important to families of these children. The current best treatment available involves implanting a temporary drainage device in a short operation. There is a new treatment called neuroendoscopic lavage (NEL), which involves the insertion of a small camera into the fluid spaces (ventricles) of the brain to wash out as much of the blood as possible before inserting the temporary drainage tube.
At present we do not know how effective this is for improving outcomes for babies with brain bleeds. The best way to find this out is with a randomised study. ENLIVEN-UK will investigate whether the addition of NEL to the standard procedure of inserting a temporary cerebrospinal fluid (CSF) drainage device will improve children's development at 2 year's of age.
The trial will recruit 100 infants from 212 or more sites across the UK. 50 infants will be randomised to receive the intervention arm (neuroendoscopic lavage, or washout, and temporary drainage device) and 50 will be randomised to the control arm (temporary drainage device alone (our best current care)). Infants will be followed up for 2 years.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
23/SW/0137
Date of REC Opinion
4 Dec 2023
REC opinion
Favourable Opinion