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NCT Number: NCT03650101

Improving Infant Hydrocephalus Outcomes in Uganda

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hydrocephalus Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

1 day–180 day

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital for Sick Children, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ETV/CPC

Procedure

The Endoscopic Third Ventriculostomy/Choroid Plexus Cauterization (ETV/CPC) will comprise a standard frontal approach with flexible endoscopy.

Primary outcomes

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

    Time frame: 24 months of age

    Scores on the BSID-3, which is used to evaluate infants and toddlers 1 to 42 months of age, range from 1 to 19, with higher scores indicating better performance; the mean (±standard deviation(SD)) score in the general population is 10±3.

  2. Incidence of ETV/CPC treatment failure

    Time frame: 6 months post-treatment

    Treatment failure or success will be determined with the use of clinical and radiographic criteria.

    • Treatment success will be determined as the shift in the growth of head circumference to a normal rate, as plotted on a standard growth chart; decompression of the anterior fontanel; relief of symptoms of elevated intracranial pressure, such as irritability and vomiting; resolution of down-gaze or sixth cranial nerve palsy; and a decrease or arrest in ventriculomegaly as determined on Computerized Tomography (CT).
    • Treatment failure will be defined as treatment-related death or the need for a second operation for infection or for the recurrence of hydrocephalus.

Secondary outcomes

  1. Cerebral oxygen metabolism

    Time frame: pre- and post-, 6, 12 months post-treatment and 24 months of age

    cerebral oxygen metabolism will be measured with near-infrared spectroscopy

  2. brain volume

    Time frame: pre-, 6, 12 months post-treatment and 24 months of age

    brain volume will be quantitatively estimated from the head CT scan

  3. Bayley Scales of Infant Development, Third Edition (BSID-3), cognitive scaled score at 12 months post-treatment

    Time frame: 12 months post-treatment

    Scores on the BSID-3, which is used to evaluate infants and toddlers 1 to 42 months of age, range from 1 to 19, with higher scores indicating better performance; the mean (±standard deviation) score in the general population is 10±3.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • CURE Children's Hospital, Uganda
  • The Hospital for Sick Children
  • Yale University

Registry information

Official study title

Improving Infant Hydrocephalus Outcomes in Uganda: Predicting Developmental Outcomes and Identifying Patients at Risk for Early Treatment Failure After ETV/CPC

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Aug 28, 2018
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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