The Comprehensive Clinical Trials Unit at UCL



Developmental Optimisation using Lavage in Preterm Haemorrhage in Infants in the UK: A national randomised controlled trial on the efficacy of neuro-endoscopic lavage

18 July 2023


DOLPHIN-UK is a phase-III, multicentre, randomised, assessor-blinded, controlled trial of Neuroendoscopic levage (NEL) with temporising device (intervention arm) vs temporising device alone (standard treatment arm) in preterm infants with intraventricular haemorrhaging and post-haemorrhagic ventricular dilatation with an internal pilot study.

Status: Set up
Funder: National Institute for Health and Care Research (NIHR HTA)
ISRCTN: Registration in progress

Chief investigator: Mr. Kristian Aquilina, Consultant Paediatric Neurosurgeon (Great Ormond Street Hospital)

Heath condition: Post-haemorrhagic hydrocephalus
Intervention: Neuroendoscopic levage (NEL) with temporising device
Control: Temporising device alone
Key outcomes: Cognitive quotient (CQ) at 2 years corrected age as measured by the Bayley Scales of Infant and Toddler Development (fourth edition)
Setting: Paediatric neurosurgical units
Duration: 72 months (participants involved from pre-term birth through ~2 years old)

Target date for first enrolment: September 2023
Target sample size: 100
Target sites: 13