Improving Infant Hydrocephalus Outcomes in Uganda

Recruiting

• Conditions: Hydrocephalus
• Interventions: Procedure: ETV/CPC

• Registration Number: NCT03650101
• Lead Sponsor: Boston Children's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-08-24
• Study First Posted: 2018-08-28
• Study Start: 2021-05-05
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14
• Primary Completion: 2025-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hydrocephalus group	ETV/CPC	Inclusion criteria: 1. Age less than six months 2. Symptomatic hydrocephalus characterized by abnormal rate of head growth, full anterior fontanel, ventriculomegaly 3. A parent or a guardian qualified by Ugandan law to give informed consent 4. Patients from Eastern, Central and Northern districts of Uganda, and in geographic proximity to CURE hospital will be eligible Exclusion criteria: 1. Age greater than six months 2. No evidence of progressive hydrocephalus 3. Patients outside of the districts specified in the inclusion criteria

Primary Outcome Measures

Name	Time	Method
Bayley Scales of Infant Development, Third Edition (BSID-3), cognitive scaled score	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.
Incidence of ETV/CPC treatment failure	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 Outcome Measures

Name	Time	Method
brain volume	pre-, 6, 12 months post-treatment and 24 months of age	brain volume will be quantitatively estimated from the head CT scan
Cerebral oxygen metabolism	pre- and post-, 6, 12 months post-treatment and 24 months of age	cerebral oxygen metabolism will be measured with near-infrared spectroscopy
Bayley Scales of Infant Development, Third Edition (BSID-3), cognitive scaled score at 12 months post-treatment	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.

Trial Locations

Locations (3)

Penn State University; 🇺🇸 University Park, Pennsylvania, United States

Cure Children's Hospital of Uganda; 🇺🇬 Mbale, Uganda

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada