Improving Infant Hydrocephalus Outcomes in Uganda

NCT03650101 | Active Not Recruiting

• 1 other identifier: P00029806
• Study Type: observational
• Target: 400
• Locations: 3 countries
• Sites: 3

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.

Conditions

Hydrocephalus

Keywords

Hydrocephalus

Outcome Measures

Primary Outcomes (2)

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

  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.

  24 months of age

• Incidence of ETV/CPC treatment failure

  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.

  6 months post-treatment

Secondary Outcomes (3)

• Cerebral oxygen metabolism

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

• brain volume

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

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

  12 months post-treatment

Study Arms (2)

Hydrocephalus group

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

Procedure: ETV/CPC

Control group

Inclusion criteria: 1. Born at GA ≥ 37 weeks 2. Age less than six months at the time of enrollment 3. No known medical conditions 4. With a parent or a guardian qualified by Ugandan law to give informed consent 5. Parents live in one of the villages in the Mbale or Budaka District, in geographic proximity to CCHU. Exclusion criteria: 1. Born at GA \< 37 weeks 2. Age greater than six months 3. Evidence of one or more medical conditions 4. Living outside of the districts specified in the inclusion criteria.

Interventions

ETV/CPC PROCEDURE

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

Hydrocephalus group

Eligibility Criteria

• Age: 1 Day - 180 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Infants less than six months old with progressive hydrocephalus

You may qualify if:

• 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

You may not qualify if:

• Age greater than six months
• No evidence of progressive hydrocephalus

Sponsors & Collaborators

• Boston Children's Hospital: lead
• The Hospital for Sick Children: collaborator
• CURE Children's Hospital, Uganda: collaborator
• Yale University: collaborator

Study Sites (3)

Penn State University

University Park, Pennsylvania, 16802, United States

Location

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

Cure Children's Hospital of Uganda

Mbale, Uganda

Location

Related Publications (1)

• Vadset TA, Rajaram A, Hsiao CH, Kemigisha Katungi M, Magombe J, Seruwu M, Kaaya Nsubuga B, Vyas R, Tatz J, Playter K, Nalule E, Natukwatsa D, Wabukoma M, Neri Perez LE, Mulondo R, Queally JT, Fenster A, Kulkarni AV, Schiff SJ, Grant PE, Mbabazi Kabachelor E, Warf BC, Sutin JDB, Lin PY. Improving Infant Hydrocephalus Outcomes in Uganda: A Longitudinal Prospective Study Protocol for Predicting Developmental Outcomes and Identifying Patients at Risk for Early Treatment Failure after ETV/CPC. Metabolites. 2022 Jan 14;12(1):78. doi: 10.3390/metabo12010078.

  RESULT

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Pei-Yi Lin, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 28, 2018
• Study Start: May 5, 2021
• Primary Completion: May 15, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1); US (1); CA (1)