Advanced MRI in IVH

NCT07412886 | Not Yet Recruiting

• 1 other identifier: 24BI28
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Intraventricular Hemorrhage Neonatal; Post-hemorrhagic Hydrocephalus

Keywords

intraventricular hemorrhage; post-hemorrhagic ventricular dilatation; magnetic resonance imaging; cognitive development

Outcome Measures

Primary Outcomes (1)

• Feasibility

  Number (percentage) of patients completing total scan protocol

  At the time of scan (18 months)

Secondary Outcomes (2)

• Scan quality

  At end of study period (18 months)

• Correlation to developmental outcomes

  At end of study (18 months)

Study Arms (1)

Advanced MRI Sqeuences

EXPERIMENTAL

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

Diagnostic Test: Advanced MRI

Interventions

Advanced MRI DIAGNOSTIC_TEST

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

Advanced MRI Sqeuences

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead
• Alder Hey Children's NHS Foundation Trust: collaborator

Study Sites (2)

Alder Hey Children's Hospital

Liverpool, United Kingdom

Location

Great Ormond Street Hospital for Children

London, United Kingdom

Location

Central Study Contacts

Kristian Aquilina, PhD, FRCS (SN)

CONTACT

+442074059200; kristian.aquilina@gosh.nhs.uk

Aswin Chari, PhD, FRCS (SN)

CONTACT

+442074059200; aswin.chari.18@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective cohort study at 2 centres over 18 months

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 17, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

GB (2)