Improving outcomes for infants with hydrocephalus in Uganda
Improving Infant Hydrocephalus Outcomes in Uganda: Predicting Developmental Outcomes and Identifying Patients at Risk for Early Treatment Failure After ETV/CPC
This study is testing a new treatment for infants with hydrocephalus in Uganda to see if it works better than traditional methods that often fail.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 1 Day to 180 Days |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 3 sites (University Park, Pennsylvania and 2 other locations) |
| Trial ID | NCT03650101 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on neonatal postinfectious hydrocephalus in East Africa, where traditional treatment methods like ventriculoperitoneal shunts often fail. The study aims to evaluate the effectiveness of Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV/CPC) as an alternative treatment that could potentially eliminate the need for shunts. Researchers will optimize metrics for evaluating treatment response and long-term outcomes in infants under six months old who exhibit symptomatic hydrocephalus. The study will involve collaboration between several prominent institutions and hospitals in Uganda and North America.
Who should consider this trial
Good fit: Ideal candidates for this study are infants under six months old with symptomatic hydrocephalus living in specific districts of Uganda.
Not a fit: Patients over six months old or those without evidence of progressive hydrocephalus will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide infants with a more effective, shunt-free treatment for hydrocephalus, improving their long-term health outcomes.
How similar studies have performed: Other studies have shown promise with ETV/CPC as a treatment for hydrocephalus, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
University Park, Pennsylvania and 2 other locations
- Penn State University — University Park, Pennsylvania, United States (Active_not_recruiting)
- The Hospital for Sick Children — Toronto, Ontario, Canada (Active_not_recruiting)
- Cure Children's Hospital of Uganda — Mbale, Uganda (Recruiting)
Study contacts
- Principal investigator: Pei-Yi Lin, PhD — Boston Children's Hospital
- Study coordinator: Pei-Yi Lin, PhD
- Email: Ivy.Lin@childrens.harvard.edu
- Phone: 6179191308
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.