Endoscopic lavage after intraventricular haemorrhage in neonates in the UK (ENLIVEN-UK): study protocol for a national randomised-controlled trial
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Published on: August 25, 2022
Saniya Mediratta1, Aswin Chari2, Cheryl Battersby3
1University College London Hospitals NHS Foundation Trust (UCLH), London, UK. saniya.mediratta@gmail.com.
Insights
This trial investigates if neuroendoscopic lavage (NEL) improves neurodevelopmental outcomes in preterm infants with intraventricular haemorrhage (IVH) and post-haemorrhagic ventricular dilatation (PHVD). Results will determine if NEL can enhance care for these vulnerable newborns.
Area of Science:
- Neonatal neurosurgery
- Pediatric neurology
- Clinical trial methodology
Background:
- Intraventricular haemorrhage (IVH) is a severe complication in preterm infants, often leading to post-haemorrhagic ventricular dilatation (PHVD).
- PHVD significantly increases the risk of long-term neurodevelopmental impairment in affected neonates.
- Current treatments involve temporary cerebrospinal fluid (CSF) diversion, with limited impact on long-term outcomes.
Purpose of the Study:
- To evaluate the efficacy of neuroendoscopic lavage (NEL) as an adjunct to standard temporising device placement for severe IVH and PHVD.
- To determine if NEL improves neurodevelopmental outcomes at 2 years corrected age in preterm infants.
- To provide level 1 evidence on the safety and effectiveness of NEL in this vulnerable population.
Main Methods:
- A national, multicentre, superiority randomised controlled trial (RCT) enrolling 100 preterm infants with severe IVH and PHVD.
- Infants randomized 1:1 to standard temporising device placement or NEL plus temporising device placement.
- Primary outcome: cognitive quotient (CQ) at 2 years corrected age assessed by Bayley-IV; secondary outcomes include motor/language development, VP shunt requirement, complications, quality of life, and costs.
Main Results:
- This section is not applicable as the study is ongoing and results are not yet available.
Conclusions:
- The ENLIVEN-UK trial aims to provide definitive evidence on the role of NEL in managing preterm infants with IVH and PHVD.
- Successful outcomes could lead to a paradigm shift in the standard of care for this condition.
- Improved neurodevelopmental outcomes are anticipated if NEL proves effective and safe.
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.
