Active — Not RecruitingNot Applicable

Improving Infant Hydrocephalus Outcomes in Uganda

United States, Canada, Uganda400 participantsStarted 2021-05-05

Plain-language summary

Neonatal postinfectious hydrocephalus (PIH) is a major public health problem in East Africa.The standard treatment has long been placement of a ventriculoperitoneal shunt (VPS) but these devices require life-long maintenance and nearly all fail multiple times. Endoscopic Third Ventriculostomy (ETV) with Choroid Plexus Cauterization (ETV/CPC) is an alternate treatment to give patients a shunt-free life. In this study, the investigators aim to optimize the metrics of evaluation as quantitative prognostic indicators of treatment response and long term outcomes.

Who can participate

Age range1 Day – 180 Days

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Infants less than 180 days (six months) old * Symptomatic hydrocephalus characterized by abnormal rate of head growth, full anterior fontanel, ventriculomegaly * A parent or a guardian qualified by Ugandan law to give informed consent * Patients from Eastern, Central and Northern districts of Uganda, and in geographic proximity to CURE hospital will be eligible Exclusion Criteria: * Age greater than six months * No evidence of progressive hydrocephalus * Patients outside of the districts specified in the inclusion criteria

What they're measuring

Bayley Scales of Infant Development, Third Edition (BSID-3), cognitive scaled score

Timeframe: 24 months of age

Incidence of ETV/CPC treatment failure

Timeframe: 6 months post-treatment

Trial details

NCT IDNCT03650101

SponsorBoston Children's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-05-15

View on ClinicalTrials.gov More Hydrocephalus trials