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Active, Not Recruiting

NCT Number: NCT01936272

Randomized Controlled Trial of Shunt vs ETV/CPC for PIH in Ugandan Infants

Two treatment options exist for infant patients with hydrocephalus. Most patients are treated with a surgical procedure in which a shunt is inserted into the brain and abdomen. In recent years, however, another treatment has developed called Endoscopic Third Ventriculostomy (ETV) with Choroid Plexus Cauterization (ETV/CPC).This research study is being done to measure the results of these procedures in children less than six months of age who have hydrocephalus as the result of a brain infection, called post-infectious hydrocephalus, or PIH. This study will evaluate patients in more detail to measure brain growth and development.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

1 day–180 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CURE Children's Hospital Uganda

Mbale, Uganda

About this study

World over, infants with hydrocephalus are mainly treated using a shunt, which is a device made of soft plastic tubing that moves extra fluid from the brain to the abdomen. Surgery is required to insert a shunt into the brain and the abdomen. In recent years, we have developed another treatment called Endoscopic Third Ventriculostomy (ETV) with Choroid Plexus Cauterization (ETV/CPC). This research study is being done to measure the results of these procedures in children less than six months of age who have hydrocephalus as the result of a brain infection, called post-infectious hydrocephalus, or PIH. This is the most common cause of hydrocephalus in Ugandan babies. This study will evaluate patients in more detail to measure brain growth and development. Children in the study will have special testing to measure developmental progress as well as special imaging to evaluate the progress of their brain growth.

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
  • Post-infectious Hydrocephalus based on clinical and CT parameters2
  • Must be from the following Ugandan districts: Bugiri, Busia, Iganga, Jinja, Kampala, Kamuli, Kapchorwa, Katakwi, Kumi, Mayuge, Mbale, Mukono, Pallisa, Sironko, Soroti, and Tororo

Exclusion criteria

  • Any patient with a scalp erosion or infection that would exclude the patient from shunt implantation
  • Any patient with ventricular loculations that would normally indicate the use of ventriculoscopy as an adjunct to shunt placement
  • Any patient with absence of any visible cortical mantle on the CT
  • Patients must be appropriate candidates for either surgical procedure - shunt placement alone or ETV/CPC

Treatment and study plan

Chhabra Shunt Placement

Device

ETV/CPC

Procedure

Primary outcomes

  1. Change of Age-normed Bayley Scales of Infant Development (BSID)-III scores

    Time frame: 12 months and 24 months post treatment

    Neurocognition will be measured using the BSID-III Cognitive Scale. Change will be assessed at 24 months post treatment from baseline score (12 months post treatment).

Secondary outcomes

  1. Brain Volume

    Time frame: 12 months, 24 months, 5 years, and 7-10 years post treatment

    Volume unit of measure is cubic millimeters. Volume is measured using CT scans.

  2. CSF Volume

    Time frame: 12 months, 24 months, 5 years, and 7-10 years post treatment

    Volume unit of measure is cubic millimeters. Volume is measured using CT scans.

  3. Vineland Adaptive Behavior Scales

    Time frame: 5 years and 7-10 years post treatment

    The primary purpose of the VABS is to assess the social abilities of school age children.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

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

Registry information

Official study title

Neurocognitive Outcomes and Changes in Brain and Cerebral Spinal Fluid (CSF) Volume After Treatment of Post-Infectious Hydrocephalus (PIH) in Ugandan Infants by Shunting Versus ETV/CPC

Important dates

Study start
2013
Primary completion
2026
Study completion
2026
First posted
Sep 6, 2013
Registry last updated
May 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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