HCRN 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 l
| Condition(s) | Hydrocephalus |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 o |
| Ages | 1 Day to 104 Weeks |
| Sex | All |
| Lead sponsor | University of Utah |
| Locations | Birmingham, Alabama, United States; Phoenix, Arizona, United States; Los Angeles, California, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States; Jacksonville, Florida, United States (+15 more sites) |
| Start date | 2020-07-21 |
| NCT ID | NCT04177914 |
| Official listing | https://clinicaltrials.gov/study/NCT04177914 |