HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

A vizsgálat adatai

Ki végzi

University of Utah

Azonosító

NCT04177914

A regiszteradat frissítve

2026. szeptember 25.

Eredeti leírás

Hydrocephalus is a potentially debilitating neurological condition that primarily affects babies under a year of age and has traditionally been treated by inserting a shunt between the brain and the abdomen. A newer endoscopic procedure offers hope of shunt- free treatment that may reduce complications over a child's life, but it is not clear if the endoscopic procedure results in similar intellectual outcome as shunt. Therefore, the investigators propose a randomized trial to compare intellectual outcome and brain structural integrity between these two treatments, to help families make the best treatment decision for their baby.A teljes eredeti leírásKevesebb

Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

Hydrocephalus is a potentially debilitating neurological condition that primarily affects babies under a year of age and has traditionally been treated by inserting a shunt between the brain and the abdomen. A newer endoscopic procedure offers hope of shunt- free treatment that may reduce complications over a child's life, but it is not clear if the endoscopic procedure results in similar intellectual outcome as shunt. Therefore, the investigators propose a randomized trial to compare intellectual outcome and brain structural integrity between these two treatments, to help families make the best treatment decision for their baby.

Bevonási feltételek: Corrected age <104 weeks and 0 days,; AND; Child is ≥ 37 weeks post menstrual age,; AND; Child must have symptomatic hydrocephalus, defined as:; Ventriculomegaly on MRI (frontal-occipital horn ratio (FOR) >0.45, which approximates "moderate ventriculomegaly"), and at least one of the following:; Head circumference >98th percentile for corrected age with either bulging fontanelle or splayed sutures; Upgaze paresis/palsy (sundowning); CSF leak; Papilledema; Tense pseudomeningocele or tense fluid along a track; Vomiting or irritability, with no other attributable cause; Bradycardias or apneas, with no other attributable cause; Intracranial pressure (ICP) monitoring showing persistent elevation of pressure with or without plateau waves; AND; No prior history of shunt insertion or endoscopic third ventriculostomy (ETV) procedure (previous temporization devices and/or external ventricular drains permissible).

Kizáró feltételek: Underlying condition with a high chance of mortality within 12 months; OR; Active CSF infection; OR; Hydrocephalus due to intraventricular hemorrhage in a child born before 37 weeks gestational age; OR; Anatomy not suitable for ETV+CPC or anteriorly placed ventriculoperitoneal shunt defined as:; Moderate to severe prepontine adhesions on steady state free precession (SSFP) or T2 weighted fast (turbo) spin echo (FSE/TSE) MRI, which includes the following sequences: FIESTA, FIESTA-C, TrueFISP, CISS, Balanced FFE (bFFE), CUBE, SPACE, VISTA, IsoFSE, and 3D MVOX; Closure of one or both foramina of Monro; Thick floor of third ventricle (≥ 3mm); Narrow third ventricle (<5mm); Presence of scalp, bone, or ventricular lesions that make placement of an anterior shunt impracticable; OR; Hydrocephalus with loculated CSF compartments; OR; Peritoneal cavity not suitable for distal shunt placement; OR; Hydranencephaly; OR; Child requires an intraventricular procedure (e.g. endoscopic biopsy) in addition to the initial first-time permanent procedure for the treatment of hydrocephalus.

ClinicalTrials.gov NCT04177914