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; Sally Jary; Charlotte Kelham; Alyson MacNeil; Sue Massingham; Neil Marlow; Amalia Ndoutoumou; Monica Panca; Victoria Pittordou; Cristine Sortica da Costa; Andrew Whitelaw; Conor Mallucci; Kristian Aquilina

doi:10.1186/s13063-025-08952-1

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, Sally Jary, Charlotte Kelham, Alyson MacNeil, Sue Massingham, Neil Marlow, Amalia Ndoutoumou, Monica Panca, Victoria Pittordou, Cristine Sortica da Costa, Andrew WhitelawConor Mallucci, Kristian Aquilina

^*Corresponding author for this work

Bristol Medical School (THS)

Research output: Contribution to journal › Article (Academic Journal) › peer-review

Abstract

Background
Intraventricular 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.

Methods
ENLIVEN-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 registration
ISRCTN Trial Registration: ISRCTN14018410.

Original language	English
Article number	464
Number of pages	12
Journal	Trials
Volume	26
Issue number	1
DOIs	https://doi.org/10.1186/s13063-025-08952-1
Publication status	Published - 3 Nov 2025

Bibliographical note

Publisher Copyright:
© The Author(s) 2025.

Keywords

Post-haemorrhagic hydrocephalus
Post-haemorrhagic ventricular dilatation
Neuroendoscopic lavage
Neurodevelopmental outcome

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Mediratta, S., Chari, A., Battersby, C., Bauserman, P., Caverly, E., Dawes, W., Dehbi, H.-M., Embleton-Thirsk, A., Galland, L., James, G., Jary, S., Kelham, C., MacNeil, A., Massingham, S., Marlow, N., Ndoutoumou, A., Panca, M., Pittordou, V., da Costa, C. S., ... Aquilina, K. (2025). Endoscopic lavage after intraventricular haemorrhage in neonates in the UK (ENLIVEN-UK): study protocol for a national randomised-controlled trial. Trials, 26(1), Article 464. https://doi.org/10.1186/s13063-025-08952-1

@article{f47bb0f0376d4e23a1c5c8ae3ef5bfeb,

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

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. DiscussionThis 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.",

keywords = "Post-haemorrhagic hydrocephalus, Post-haemorrhagic ventricular dilatation, Neuroendoscopic lavage, Neurodevelopmental outcome",

author = "Saniya Mediratta and Aswin Chari and Cheryl Battersby and Patrick Bauserman and Emilia Caverly and William Dawes and Hakim-Moulay Dehbi and Andrew Embleton-Thirsk and Laurence Galland and Gregory James and Sally Jary and Charlotte Kelham and Alyson MacNeil and Sue Massingham and Neil Marlow and Amalia Ndoutoumou and Monica Panca and Victoria Pittordou and \{da Costa\}, \{Cristine Sortica\} and Andrew Whitelaw and Conor Mallucci and Kristian Aquilina",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2025.",

year = "2025",

month = nov,

day = "3",

doi = "10.1186/s13063-025-08952-1",

language = "English",

volume = "26",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central Ltd",

number = "1",

}

Mediratta, S, Chari, A, Battersby, C, Bauserman, P, Caverly, E, Dawes, W, Dehbi, H-M, Embleton-Thirsk, A, Galland, L, James, G, Jary, S, Kelham, C, MacNeil, A, Massingham, S, Marlow, N, Ndoutoumou, A, Panca, M, Pittordou, V, da Costa, CS, Whitelaw, A, Mallucci, C & Aquilina, K 2025, 'Endoscopic lavage after intraventricular haemorrhage in neonates in the UK (ENLIVEN-UK): study protocol for a national randomised-controlled trial', Trials, vol. 26, no. 1, 464. https://doi.org/10.1186/s13063-025-08952-1

TY - JOUR

T1 - Endoscopic lavage after intraventricular haemorrhage in neonates in the UK (ENLIVEN-UK)

T2 - study protocol for a national randomised-controlled trial

AU - Mediratta, Saniya

AU - Chari, Aswin

AU - Battersby, Cheryl

AU - Bauserman, Patrick

AU - Caverly, Emilia

AU - Dawes, William

AU - Dehbi, Hakim-Moulay

AU - Embleton-Thirsk, Andrew

AU - Galland, Laurence

AU - James, Gregory

AU - Jary, Sally

AU - Kelham, Charlotte

AU - MacNeil, Alyson

AU - Massingham, Sue

AU - Marlow, Neil

AU - Ndoutoumou, Amalia

AU - Panca, Monica

AU - Pittordou, Victoria

AU - da Costa, Cristine Sortica

AU - Whitelaw, Andrew

AU - Mallucci, Conor

AU - Aquilina, Kristian

PY - 2025/11/3

Y1 - 2025/11/3

N2 - 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. DiscussionThis 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.

AB - 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. DiscussionThis 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.

KW - Post-haemorrhagic hydrocephalus

KW - Post-haemorrhagic ventricular dilatation

KW - Neuroendoscopic lavage

KW - Neurodevelopmental outcome

U2 - 10.1186/s13063-025-08952-1

DO - 10.1186/s13063-025-08952-1

M3 - Article (Academic Journal)

SN - 1745-6215

VL - 26

JO - Trials

JF - Trials

IS - 1

M1 - 464

ER -

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

Abstract

Bibliographical note

Keywords

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