Waiting for ELVIS

Abstract

Clinicians awaiting the results of randomized trials for preterm infants often have to wait for a very long time to learn the neurodevelopmental outcomes of neonatal interventions. This is highlighted this month in The Journal of Pediatrics as Cizmeci et al report brain magnetic resonance imaging (MRI) outcomes for the Early vs Late Ventricular Intervention Study (ELVIS). In this study, infants with post-hemorrhagic ventricular dilation were randomized to a low vs high threshold for intervention, beginning in 2006 and completing in 2016. No difference was noted for the primary outcome of need for ventriculoperitoneal shunt placement (Arch Dis Child Fetal Neonatal Ed 2019;104:F70-5). Because post-hemorrhagic ventricular dilation is an infrequent complication of prematurity, it took 10 years to accumulate enough patients for the primary outcome. Even now, 13 years after the onset of the trial, clinicians are awaiting the neurodevelopmental outcomes that will be available when all children have been evaluated at 24 months of corrected age. In this interim report, the ELVIS authors demonstrated improved Kidokoro scores at term equivalent age on MRI for the infants who had intervention at a low threshold compared with those who had the intervention at a higher threshold. We would like to know if the improvements in Kidokoro scores will translate to a lower incidence of cerebral palsy, developmental delays, or visual impairments in these infants. Because term equivalent age MRI findings correlate with later outcomes, we would expect this to be true. However, many clinicians will await the 24-month outcomes as the interventions (lumbar puncture, ventricular reservoirs, ventriculoperitoneal shunt) have known complications that require serious consideration and perhaps the highest level of proof that is available. Article page 191▶ Assessment of Brain Injury and Brain Volumes after Posthemorrhagic Ventricular Dilatation: A Nested Substudy of the Randomized Controlled ELVIS TrialThe Journal of PediatricsVol. 208PreviewTo compare the effect of early and late intervention for posthemorrhagic ventricular dilatation on additional brain injury and ventricular volume using term-equivalent age-MRI. Full-Text PDF