Intraventricular Hemorrhage NeonatalNCT07412886
Advanced MRI in IVH
A study testing Advanced MRI in people with Intraventricular Hemorrhage Neonatal and Post-hemorrhagic Hydrocephalus, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intraventricular Hemorrhage Neonatal, Post-hemorrhagic Hydrocephalus
- What is being tested?
- Advanced MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 16 Feb 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Neonates with PHVD who have been referred to and/or have undergone neurosurgical treatment at Great Ormond Street Hospital (GOSH) and Alder Hey Children's Hospital (AHCH) (15 neonates in each) will be eligible for inclusion.
The majority of neonates will be recruited to the ENLIVEN-UK randomised clinical trial and involvement will not preclude recruitment to this study.
The only exclusion criteria will be lack of informed consent from the parent/carer.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites
Alder Hey Children's Hospital
Liverpool
Conor Mallucci, +442074059200, CONOR.MALLUCCI@alderhey.nhs.uk
Great Ormond Street Hospital for Children
London
Kristian Aquilina, +442074059200, kristian.aquilina@gosh.nhs.uk
About this study
Official title: Advanced MRI in Preterm Intraventricular Haemorrhage: Uncovering Mechanisms of Disease and Novel Treatments
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.
Read the detailed description
Background
Post-haemorrhagic ventricular dilatation (PHVD) is the most important cause of developmental and cognitive disability after prematurity. The ENLIVEN-UK trial is an NIHR-funded multicentre national randomised study, aiming to recruit 100 neonates across 16 centres, to evaluate the impact of endoscopic lavage in addition to standard drainage of cerebrospinal fluid (CSF) at an early postnatal age. In this study we will use a set of novel MRI sequences at term-equivalent age (TEA) to assess impact of treatment and discover novel mechanisms of disease.
Objectives
- To determine the impact of standard treatment and endoscopic lavage on brain structure and function, distribution of blood products, and CSF flow using advanced MRI techniques at TEA;
- To assess how these new MRI techniques relate to prognosis, and add predictive value to the basic MRI scan carried out as standard of care, as defined by the 2-year structured formal evaluation within the ENLIVEN-UK trial and 6-monthly neurological examinations.
Methods
Neonates with PHVD undergoing neurosurgical treatment at Great Ormond Street Hospital (GOSH) and Alder Hey Children's Hospital (AHCH) (15 neonates in each), the majority of whom will be recruited to the ENLIVEN-UK study, will undergo additional novel MRI sequences at their TEA MRI scan. These will include Diffusion Tractography (DTI), DTI-along perivascular spaces (DTI-ALPS), quantitative susceptibility mapping (QSM) and resting state functional MRI (rs-fMRI) sequences. These images will be processed and evaluated by MR physicists and outcomes will be reviewed in the context of their (a) randomised surgical treatment and (b) formal developmental and cognitive evaluation at 2 years.
Outcomes
The use of these MR sequences in this population is novel. Any factors related to the impact of endoscopic lavage and prognostic significance will be evaluated in a wider neonatal cohort through the national network of neurosurgeons and neonatologists developed by the ENLIVEN-UK study.
- Being tested
- Advanced MRI
- Keywords
- intraventricular hemorrhage, post-hemorrhagic ventricular dilatation, magnetic resonance imaging, cognitive development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced MRIDiagnostic test
We will acquire advanced MRI sequences including diffusion tensor imaging (DTI), quantitative susceptibility mapping (QSM) and resting-state functional MRI (rs-fMRI)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Advanced MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Number (percentage) of patients completing total scan protocol
Measured: At the time of scan (18 months)
Secondary outcomes (2)
Scan quality
Number (percentage) of patients for whom each sequence (DTI, DTI-ALPS, QSM, fMRI) is able to be pre-processed successfully with acceptable movement/artefact.
Measured: At end of study period (18 months)
Correlation to developmental outcomes
Number of sequences (DTI, QSM and rs-fMRI) for which there is enough data to correlate with developmental outcomes
Measured: At end of study (18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start16 Feb 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraventricular Hemorrhage NeonatalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort study at 2 centres over 18 months
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Alder Hey Children's NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412886
- Sponsor's protocol ID
- 24BI28
- Status last verified
- Feb 2026
- First submitted
- 29 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Issues relating to confidentiality with MRI data
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced MRI in Preterm Intraventricular Haemorrhage: Uncovering Mechanisms of Disease and Novel Treatments
- ClinicalTrials.gov ID
- NCT07412886
- Acronym / sponsor ID
- 24BI28
- Keywords
- intraventricular hemorrhage, post-hemorrhagic ventricular dilatation, magnetic resonance imaging, cognitive development
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Alder Hey Children's NHS Foundation Trust
- Study start
- 16 Feb 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background
Post-haemorrhagic ventricular dilatation (PHVD) is the most important cause of developmental and cognitive disability after prematurity. The ENLIVEN-UK trial is an NIHR-funded multicentre national randomised study, aiming to recruit 100 neonates across 16 centres, to evaluate the impact of endoscopic lavage in addition to standard drainage of cerebrospinal fluid (CSF) at an early postnatal age. In this study we will use a set of novel MRI sequences at term-equivalent age (TEA) to assess impact of treatment and discover novel mechanisms of disease.
Objectives
- To determine the impact of standard treatment and endoscopic lavage on brain structure and function, distribution of blood products, and CSF flow using advanced MRI techniques at TEA;
- To assess how these new MRI techniques relate to prognosis, and add predictive value to the basic MRI scan carried out as standard of care, as defined by the 2-year structured formal evaluation within the ENLIVEN-UK trial and 6-monthly neurological examinations.
Methods
Neonates with PHVD undergoing neurosurgical treatment at Great Ormond Street Hospital (GOSH) and Alder Hey Children's Hospital (AHCH) (15 neonates in each), the majority of whom will be recruited to the ENLIVEN-UK study, will undergo additional novel MRI sequences at their TEA MRI scan. These will include Diffusion Tractography (DTI), DTI-along perivascular spaces (DTI-ALPS), quantitative susceptibility mapping (QSM) and resting state functional MRI (rs-fMRI) sequences. These images will be processed and evaluated by MR physicists and outcomes will be reviewed in the context of their (a) randomised surgical treatment and (b) formal developmental and cognitive evaluation at 2 years.
Outcomes
The use of these MR sequences in this population is novel. Any factors related to the impact of endoscopic lavage and prognostic significance will be evaluated in a wider neonatal cohort through the national network of neurosurgeons and neonatologists developed by the ENLIVEN-UK study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort study at 2 centres over 18 months
| Arm | Type | Receives |
|---|---|---|
| Advanced MRI Sqeuences | Experimental | Diagnostic Test: Advanced MRIWe will acquire advanced MRI sequences including diffusion tensor imaging (DTI), quantitative susceptibility mapping (QSM) and resting-state functional MRI (rs-fMRI) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced MRIWe 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 Sqeuences |
Primary outcome
Feasibility
Time frame: At the time of scan (18 months)
Number (percentage) of patients completing total scan protocol
2 secondary outcomes
Scan quality
Time frame: At end of study period (18 months)
Correlation to developmental outcomes
Time frame: At end of study (18 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Undecided. Issues relating to confidentiality with MRI data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced MRI in people with Intraventricular Hemorrhage Neonatal and Post-hemorrhagic Hydrocephalus, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristian Aquilina, PhD, FRCS (SN) (+442074059200 ext. 1149, kristian.aquilina@gosh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: At the time of scan (18 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.