Endoscopic clot lavage in neonatal post-haemorrhagic hydrocephalus
Research type
Research Study
Full title
Endoscopic clot lavage and subgaleal shunt for treatment of neonatal post-haemorrhagic hydrocephalus
IRAS ID
198936
Contact name
Kristian Aquilina
Contact email
Sponsor organisation
Division of Research and Innovation Great Ormond Street Hospital for Children NHS foundation Trust &
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
The impact of endoscopic clot lavage / ablation on the incidence of hydrocephalus and neurological outcome following intraventricular haemorrhage in premature neonates.
Neonates born prematurely are prone to bleeding within the fluid spaces of the brain, a condition known as intraventricular haemorrhage (IVH). Blood within the ventricles impairs the flow of cerebrospinal fluid (CSF) contributing to the fact that IVH is the commonest cause of hydrocephalus in the developed world. In addition to the risk of developing hydrocephalus, recent evidence suggests that blood within the ventricle may also adversely impact on brain development causing neurodisability.
Current best practice is to perform a ventricular subgaleal shunt (VSG), a temporising procedure to divert CSF and prevent damage to the developing brain. What we propose is to do is washout the blood from the ventricle using an endoscope (immediately prior to VSG implantation) under the premise that reducing the amount of blood clot within the CSF may reduce the rate of progressive hydrocephalus and improve outcome following IVH.
All premature neonates with evidence of IVH and progressive ventricular enlargement will be eligible for enrolment in the study. They will be randomly allocated to either the standard treatment arm i.e. VSG insertion or the intervention arm i.e neuroendoscopic clot lavage followed by VSG insertion, all other aspects of treatment will remain identical between the two sample groups. All neonates enrolled in the study will undergo neurodevelopmental assessment at two years in order to determine the impact of neuroendoscopy on outcome.
Based on the best available published evidence we predict that 50 patients will be required to definitively answer both objectives (i.e. impact on the rate of shunting and outcome at two years). At present this is a single centre study and given current referral patterns we anticipate four years of data collection will be required to meet these objectives.
REC name
London - Hampstead Research Ethics Committee
REC reference
16/LO/1792
Date of REC Opinion
25 Nov 2016
REC opinion
Further Information Favourable Opinion