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NOT YET RECRUITING
NCT07412886
NA

Advanced MRI in IVH

Sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust

View on ClinicalTrials.gov

Summary

55,000 babies are born prematurely in the UK annually. Bleeding in the fluid spaces of the brain (ventricles) is common after prematurity; in England around 450 babies suffer from severe bleeds every year. This is the most important cause of neurological disability after prematurity. Bleeding occurs in the first week of life when the brain is developing rapidly and is most vulnerable to injury. The blood and its breakdown products in the brain fluid (cerebrospinal fluid, CSF) are toxic to the developing brain and cause scarring that blocks the flow and absorption of CSF. In about half these babies, this causes fluid build-up, or post-haemorrhagic ventricular dilatation (PHVD). Current standard treatment of PHVD only drains CSF to reduce pressure inside the brain. Following early results and a successful pilot study at GOSH, we developed an NIHR-funded randomised national trial to analyse the impact of an operation to wash out blood inside the brain using a small endoscope. We will compare standard treatment (fluid drainage alone) with washout plus drainage of fluid. Premature babies typically undergo an MRI scan of the brain at their expected birth time to assess their brain injury, predict the severity of their disability and see what early rehabilitation and treatment they need. In this study we will use new MRI techniques during this scan at GOSH and Alder Hey Hospital to better understand the extent of brain injury in relation to brain structure, function and brain fluid flow. We want to see whether these will show the impact of the washout procedure, tell us about how washout works, and improve prediction of the child's disability and early treatment needs. If successful, we will apply for further funding to extend these techniques to the other centres in the UK and maximise their benefit within the NHS.

Official title: Advanced MRI in Preterm Intraventricular Haemorrhage: Uncovering Mechanisms of Disease and Novel Treatments

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-02-16

Completion Date

2027-05-01

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Advanced MRI

We will acquire advanced MRI sequences including diffusion tensor imaging (DTI), quantitative susceptibility mapping (QSM) and resting-state functional MRI (rs-fMRI)

Locations (2)

Alder Hey Children's Hospital

Liverpool, United Kingdom

Great Ormond Street Hospital for Children

London, United Kingdom