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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 6 months
Healthy Volunteers: f
View:

• 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

Locations
United States
Pennsylvania
Penn State University
ACTIVE_NOT_RECRUITING
University Park
Other Locations
Canada
The Hospital for Sick Children
ACTIVE_NOT_RECRUITING
Toronto
Uganda
Cure Children's Hospital of Uganda
RECRUITING
Mbale
Contact Information
Primary
Pei-Yi Lin, PhD
Ivy.Lin@childrens.harvard.edu
6179191308
Backup
Matthew Foster
osp@childrens.harvard.edu
6179192729
Time Frame
Start Date: 2021-05-05
Estimated Completion Date: 2026-01
Participants
Target number of participants: 400
Treatments
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
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.
Related Therapeutic Areas
Sponsors
Collaborators: Yale University, CURE Children's Hospital, Uganda, The Hospital for Sick Children
Leads: Boston Children's Hospital

This content was sourced from clinicaltrials.gov