Objectives Clot lavage following intraventricular haemorrhage (IVH) in premature neonates has been shown to reduce rates of hydrocephalus1 and improve neurodevelopmental outcome at 2 years and beyond.2 The aim of the ENLIVEN trial (IRAS: 198936 Rec Ref: 16/LO/1792) is to determine the efficacy of Endoscopic clot lavage after intraventricular haemorrhage in Neonates.
Design Single centre prospective randomised controlled clinical trial comparing standard treatment with subgaleal shunt (control arm) to endoscopic washout plus standard treatment (intervention arm).
Subjects Power calculation based on published literature1 2: 50 neonates recruited over 4 years – enrolment commenced January 2018 – current recruitment 3 neonates.
Methods Neonates with radiological evidence of IVH (ventricular index >99 th centile +4 mm). Primary outcome is the rate of permanent shunting, secondary outcomes include advanced MRI at term and six months, behavioural assessment at early middle and late infancy, biochemical analysis of CSF and blood.
Results Preliminary data from the ENLIVEN trial is presented including a full description of the radiological analysis and behavioural assessment.
Conclusions Determining how endoscopic clot lavage impacts on clinical outcome is of paramount importance in the management of neonatal IVH, the ENLIVEN trial will afford us the possibility of objectively assessing its safety and efficacy.
Schulz M, Buhrer C, Pohl-Schickinger A, et al. Neuroendoscopic lavage for the treatment of intraventricular hemorrhage and hydrocephalus in neonates. J Neurosurg Pediatr2014;13(6):626–35.
Whitelaw A, Jary S, Kmita G, et al. Randomized trial of drainage, irrigation and fibrinolytic therapy for premature infants with posthemorrhagic ventricular dilatation: developmental outcome at 2 years. Pediatrics2010;125(4):e852–e58.
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