Evidence map›Paper›PMID 41185020›Full record

ArticleTrials2025

Endoscopic lavage after intraventricular haemorrhage in neonates in the UK (ENLIVEN-UK): study protocol for a national randomised-controlled trial.

Saniya Mediratta, Aswin Chari, Cheryl Battersby, Patrick Bauserman, Emilia Caverly, William Dawes, Hakim-Moulay Dehbi, Andrew Embleton-Thirsk, Laurence Galland, Gregory James and 12 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Saniya MedirattaUniversity College London Hospitals NHS Foundation Trust (UCLH), London, UK. saniya.mediratta@gmail.com.ORCID http://orcid.org/0000-0002-5187-140X
Aswin ChariGreat Ormond Street Hospital for Children NHS Foundation Trust (GOSH), London, UK.
Cheryl BattersbyImperial College London, London, UK.
Patrick BausermanUniversity College London (UCL), London, UK.
Emilia CaverlyComprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, UCL, London, UK.
William DawesBarts Health NHS Trust, London, UK.
Hakim-Moulay DehbiComprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, UCL, London, UK.
Andrew Embleton-ThirskComprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, UCL, London, UK.
Laurence GallandIndependent Parent, PPI Lead, London, UK.
Gregory JamesGreat Ormond Street Hospital for Children NHS Foundation Trust (GOSH), London, UK.
Sally JaryUniversity of Bristol, Bristol, UK.
Charlotte KelhamComprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, UCL, London, UK.
Alyson MacNeilComprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, UCL, London, UK.
Sue MassinghamComprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, UCL, London, UK.
Neil MarlowUniversity of Bristol, Bristol, UK.
Amalia NdoutoumouComprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, UCL, London, UK.
Monica PancaComprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, UCL, London, UK.
Victoria PittordouComprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, UCL, London, UK.
Cristine Sortica da CostaGreat Ormond Street Hospital for Children NHS Foundation Trust (GOSH), London, UK.
Andrew WhitelawIndependent Co-Applicant, Bristol, UK.
Conor MallucciAlder Hey Children's NHS Foundation Trust, Liverpool, UK.
Kristian AquilinaGreat Ormond Street Hospital for Children NHS Foundation Trust (GOSH), London, UK.

Funding

National Institute for Health Research Health Protection Research Unit NIHR151288
6 · The paper itself

Abstract

backgroundIntraventricular haemorrhage (IVH) is a common and severe complication of preterm birth, affecting nearly 500 neonates annually in the UK. Over 50% of infants with IVH develop post-haemorrhagic ventricular dilatation (PHVD), which is associated with significant long-term neurodevelopmental impairment. Current treatment strategies involve the use of temporary CSF diversion, through options such as ventricular access devices (VADs) or ventricular subgaleal shunts (VSGS). Neuroendoscopic lavage (NEL) is an emerging technique that aims to directly reduce the load of intraventricular blood and its breakdown products, potentially reducing the risk of secondary brain injury. The ENLIVEN-UK trial aims to assess whether the addition of NEL to standard temporising device placement improves neurodevelopmental outcomes at 2 years of corrected age compared to temporising device placement alone.

methodsENLIVEN-UK is a national, multicentre, parallel-group, assessor-blinded, superiority randomised controlled trial (RCT) that aims to enrol 100 preterm infants with severe IVH and PHVD across UK paediatric neurosurgical centres. Infants will be randomised in a 1:1 ratio to receive either standard temporising device placement or NEL in addition to temporising device placement. Randomisation will be performed using a secure online system (Sealed Envelope), with outcome assessors and statisticians blinded to treatment allocation. The primary outcome measure will be cognitive quotient (CQ) at 2 years of corrected age, assessed using the Bayley Scales of Infant and Toddler Development (4th edition, Bayley-IV). Secondary outcomes will include motor and language development, the requirement for permanent CSF diversion with a ventriculoperitoneal (VP) shunt, surgical complications, health-related quality of life (EQ-5D-5L, TAPQOL), and healthcare costs. DISCUSSION: This study aims to provide level 1 evidence regarding the efficacy and safety of NEL in preterm infants with IVH and PHVD. If successful, this trial has the potential to change the standard of care and improve long-term neurodevelopmental outcomes in this cohort of patients.

trial registrationISRCTN Trial Registration: ISRCTN14018410.

Indexed as

Cerebral HemorrhageCerebral Intraventricular HemorrhageNeuroendoscopyTherapeutic IrrigationAge FactorsChild DevelopmentEquivalence Trials as TopicFemaleHumansInfantInfant, NewbornInfant, PrematureMulticenter Studies as TopicTime FactorsTreatment OutcomeUnited KingdomNeurodevelopmental outcomeNeuroendoscopic lavagePost-haemorrhagic hydrocephalusPost-haemorrhagic ventricular dilatation

Identifiers

PMID41185020
PMCPMC12581230

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.