MedTrace Logo

Advanced MRI in IVH

NCT07412886 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-17

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Alder Hey Children's NHS Foundation Trust

    collaborator OTHER

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-16
Primary Completion
2027-05-01
Completion
2027-05-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07412886 on ClinicalTrials.gov