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NCT04177914Possibly a fitRecruiting

Compare endoscopy vs shunt surgery for infant hydrocephalus

Hydrocephalus

Part of Brain & nervous system clinical trials.

This Phase 3 study compares two common surgery options to treat hydrocephalus (extra fluid in the brain) in infants. It aims to find which approach works better and is safer for babies who have symptoms and need a first permanent treatment.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 3
Enrollment
176 people
Ages
1 day to 2 years
Study type
Interventional

Who can take part

  • Your baby must be younger than 104 weeks old (corrected age).
  • Your baby must have been born at least 37 weeks gestational age (post menstrual age).
  • Your baby must have symptomatic hydrocephalus confirmed on MRI and exam, such as an enlarged brain fluid spaces plus at least one symptom (like fast-growing head, bulging fontanelle, “sundowning,” CSF leak, eye swelling, persistent vomiting/irritability, breathing/heart pauses, or high brain pressure on monitoring).
  • This must be the first time your baby needs a permanent hydrocephalus procedure—no prior shunt or endoscopic third ventriculostomy (ETV).
  • MRI and brain anatomy must allow the study’s surgery options (endoscopy and/or an anterior shunt).
  • There should not be certain serious exceptions (for example, hydrocephalus caused by bleeding in a very premature baby, blocked/compartment fluid, active CSF infection, or a condition with high risk of death within 12 months).

View the official record on ClinicalTrials.gov

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