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The International Infant Hydrocephalus Study: concept and rational
S Sgouros1, A V Kulkharni, S Constantini
1Birmingham Children's Hospital, Birmingham, UK.
Summary
This study compares endoscopic third ventriculostomy with shunting in infants with aqueduct stenosis, focusing on quality of life outcomes. The International Infant Hydrocephalus Study aims to resolve debates on neuroendoscopic procedures versus traditional shunting.
Area of Science:
- Pediatric Neurosurgery
- Neuroendoscopy
- Hydrocephalus Management
Background:
- A need exists to scientifically compare neuroendoscopic procedures with shunting for hydrocephalus.
- Long-standing debates require resolution regarding the efficacy of these treatment options.
Purpose of the Study:
- To conduct a prospective randomized controlled trial comparing endoscopic third ventriculostomy (ETV) with shunting in infants.
- To assess the overall health-related quality of life at 5 years of age as the primary outcome.
Main Methods:
- The International Infant Hydrocephalus Study (IIHS) is a randomized trial for children under 2 years with pure aqueduct stenosis.
- Focus on neurodevelopmental outcomes, with secondary analysis of complications, reoperations, hospitalization, and costs.
- Intention-to-treat analysis based on the initial surgical procedure.
Main Results:
- Recruitment for this rare condition is ongoing across over 25 international centers.
- The study aims to recruit 91 patients per arm over a 2-year period.
- Patient recruitment has commenced in several countries.
Conclusions:
- The trial is expected to provide evidence-based answers on the value of neuroendoscopy in pediatric hydrocephalus.
- It aims to foster a collaborative network among pediatric neurosurgeons for future research.