HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

Launched by UNIVERSITY OF UTAH · Nov 22, 2019

Keywords

ClinConnect Summary

The HCRN clinical trial is researching two different treatments for hydrocephalus in infants, a condition where excess fluid builds up in the brain. Traditionally, this is treated by placing a shunt, a small tube that helps drain the fluid. However, a newer method called endoscopic treatment may provide a way to manage this condition without the need for a shunt, possibly reducing long-term complications in children. This trial will compare the effects of both treatments on how well children think and learn, as well as the health of their brains, to help families choose the best option for their baby.

To be eligible for the trial, infants must be under 104 weeks old and show signs of hydrocephalus, like an unusually large head size or developmental issues, confirmed by medical imaging. They should not have previously received a shunt or certain other procedures. Families who participate can expect close monitoring and follow-up to assess their child's progress over time. This study is currently recruiting participants and aims to provide important insights to improve treatment decisions for infants with this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Corrected age \<104 weeks and 0 days,
• • AND
• • 2. Child is ≥ 37 weeks post menstrual age,
• • AND
• 3. 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
• • 4. No prior history of shunt insertion or endoscopic third ventriculostomy (ETV) procedure (previous temporization devices and/or external ventricular drains permissible)
• Exclusion Criteria:
• • 1. Hydrocephalus due to intraventricular hemorrhage in a child born before 37 weeks gestational age; OR
• 2. 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
• • 3. Underlying condition with a high chance of mortality within 12 months; OR
• • 4. Hydrocephalus with loculated CSF compartments; OR
• • 5. Peritoneal cavity not suitable for distal shunt placement; OR
• • 6. Active CSF infection; OR
• • 7. Hydranencephaly; OR
• • 8. Child requires an intraventricular procedure (e.g. endoscopic biopsy) in addition to the initial first-time permanent procedure for the treatment of hydrocephalus.