Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
400 participants
OBSERVATIONAL
2021-05-05
2026-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Randomized Controlled Trial of Shunt vs ETV/CPC for PIH in Ugandan Infants
NCT01936272
HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
NCT04177914
A Study Comparing Two Treatments for Infants With Hydrocephalus
NCT00652470
Precision Surgery for Pediatric Hydrocephalus: VPS vs. ETV With ML-Guided Prediction
NCT07330206
The Ventricular Catheter Placement Study: Assessment of Efficacy and Safety of an Ultrasound Guided Shunt Insertion Technique
NCT01007786
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
ETV/CPC
The Endoscopic Third Ventriculostomy/Choroid Plexus Cauterization (ETV/CPC) will comprise a standard frontal approach with flexible endoscopy.
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ETV/CPC
The Endoscopic Third Ventriculostomy/Choroid Plexus Cauterization (ETV/CPC) will comprise a standard frontal approach with flexible endoscopy.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* No evidence of progressive hydrocephalus
1 Day
180 Days
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Hospital for Sick Children
OTHER
CURE Children's Hospital, Uganda
OTHER
Yale University
OTHER
Boston Children's Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pei-Yi Lin
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pei-Yi Lin, PhD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Penn State University
University Park, Pennsylvania, United States
The Hospital for Sick Children
Toronto, Ontario, Canada
Cure Children's Hospital of Uganda
Mbale, , Uganda
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P00029806
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.