HydrocephalusPhase 3NCT01936272
Randomized Controlled Trial of Shunt vs ETV/CPC for PIH in Ugandan Infants
A Phase 3 study testing Chhabra Shunt Placement and ETV/CPC in people with Hydrocephalus, run by Boston Children's Hospital at 1 site in Uganda.
Trial summary
Two treatment options exist for infant patients with hydrocephalus. Most patients are treated with a surgical procedure in which a shunt is inserted into the brain and abdomen. In recent years, however, another treatment has developed called Endoscopic Third Ventriculostomy (ETV) with Choroid Plexus Cauterization… Read more about this study
- Who is it for?
- Ages 1 day to 180 days
- Conditions the study is for
- Hydrocephalus
- What is being tested?
- Chhabra Shunt Placement and ETV/CPC
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUganda
- Study dates
- 27 May 2013to Oct 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 180 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants less than 180 days (six months) old
- Symptomatic hydrocephalus
- Post-infectious Hydrocephalus based on clinical and CT parameters2
- Must be from the following Ugandan districts: Bugiri, Busia, Iganga, Jinja, Kampala, Kamuli, Kapchorwa, Katakwi, Kumi, Mayuge, Mbale, Mukono, Pallisa, Sironko, Soroti, and Tororo
Who cannot join
- Any patient with a scalp erosion or infection that would exclude the patient from shunt implantation
- Any patient with ventricular loculations that would normally indicate the use of ventriculoscopy as an adjunct to shunt placement
- Any patient with absence of any visible cortical mantle on the CT
- Patients must be appropriate candidates for either surgical procedure - shunt placement alone or ETV/CPC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurocognitive Outcomes and Changes in Brain and Cerebral Spinal Fluid (CSF) Volume After Treatment of Post-Infectious Hydrocephalus (PIH) in Ugandan Infants by Shunting Versus ETV/CPC
Two treatment options exist for infant patients with hydrocephalus. Most patients are treated with a surgical procedure in which a shunt is inserted into the brain and abdomen. In recent years, however, another treatment has developed called Endoscopic Third Ventriculostomy (ETV) with Choroid Plexus Cauterization (ETV/CPC).This research study is being done to measure the results of these procedures in children less than six months of age who have hydrocephalus as the result of a brain infection, called post-infectious hydrocephalus, or PIH. This study will evaluate patients in more detail to measure brain growth and development.
Read the detailed description
World over, infants with hydrocephalus are mainly treated using a shunt, which is a device made of soft plastic tubing that moves extra fluid from the brain to the abdomen. Surgery is required to insert a shunt into the brain and the abdomen. In recent years, we have developed another treatment called Endoscopic Third Ventriculostomy (ETV) with Choroid Plexus Cauterization (ETV/CPC). This research study is being done to measure the results of these procedures in children less than six months of age who have hydrocephalus as the result of a brain infection, called post-infectious hydrocephalus, or PIH. This is the most common cause of hydrocephalus in Ugandan babies. This study will evaluate patients in more detail to measure brain growth and development. Children in the study will have special testing to measure developmental progress as well as special imaging to evaluate the progress of their brain growth.
- Conditions
- Hydrocephalus
- Being tested
- Chhabra Shunt Placement, ETV/CPC
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chhabra Shunt PlacementDevice
ETV/CPCProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Chhabra Shunt Placement | Active comparator | The shunting arm will comprise a standard frontal approach ventriculoperitoneal shunt using a silastic Chhabra system. Receives: Device: Chhabra Shunt Placement |
| ETV/CPC | Active comparator | The Endoscopic Third Ventriculostomy/Choroid Plexus Cauterization (ETV/CPC) arm will comprise a standard frontal approach with flexible endoscopy. Receives: Procedure: ETV/CPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Age-normed Bayley Scales of Infant Development (BSID)-III scores
Neurocognition will be measured using the BSID-III Cognitive Scale. Change will be assessed at 24 months post treatment from baseline score (12 months post treatment).
Measured: 12 months and 24 months post treatment
Secondary outcomes (3)
Brain Volume
Volume unit of measure is cubic millimeters. Volume is measured using CT scans.
Measured: 12 months, 24 months, 5 years, and 7-10 years post treatment
CSF Volume
Volume unit of measure is cubic millimeters. Volume is measured using CT scans.
Measured: 12 months, 24 months, 5 years, and 7-10 years post treatment
Vineland Adaptive Behavior Scales
The primary purpose of the VABS is to assess the social abilities of school age children.
Measured: 5 years and 7-10 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2013 (estimated)
- Study start27 May 2013
- Primary completionJun 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University, The Hospital for Sick Children, CURE Children's Hospital, Uganda
- Responsible party
- Principal investigator, Benjamin C. Warf, Boston Children's Hospital
- Investigators
- Benjamin C Warf, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936272
- Sponsor's protocol ID
- P00002785
- Status last verified
- Apr 2025
- First submitted
- 29 Jul 2013
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: IPD will not be shared with researchers outside of the study team.
Publications
Rattani A, Spencer JC, Agwu CK, Dewan MC, Kabachelor EM, Ssenyonga P, Mugamba J, Schiff SJ, Kulkarni AV, Warf BC. Five-Year Cost-Effectiveness Analysis of Endoscopic Third Ventriculostomy With Choroid Plexus Cauterization Versus Ventriculoperitoneal Shunting in Postinfectious Hydrocephalus in a Low-Income Setting. Neurosurgery. 2026 Sep 18. doi: 10.1227/neu.0000000000004218. Online ahead of print.
PubMed 42757834Mukherjee S, Templeton K, Tindimwebwa S, Lin PY, Sutin J, Yu M, Peterson M, Truwit C, Schiff SJ, Monga V. GLAPAL-H: Global, Local, and Parts Aware Learner for Hydrocephalus Infection Diagnosis in Low-Field MRI. IEEE Trans Biomed Eng. 2026 Jan;73(1):139-152. doi: 10.1109/TBME.2025.3578541.
PubMed 40489263Harper JR, Cherukuri V, O'Reilly T, Yu M, Mbabazi-Kabachelor E, Mulando R, Sheth KN, Webb AG, Warf BC, Kulkarni AV, Monga V, Schiff SJ. Assessing the utility of low resolution brain imaging: treatment of infant hydrocephalus. Neuroimage Clin. 2021;32:102896. doi: 10.1016/j.nicl.2021.102896. Epub 2021 Nov 23.
PubMed 34911199Punchak M, Mbabazi Kabachelor E, Ogwal M, Nalule E, Nalwoga J, Ssenyonga P, Mugamba J, Rattani A, Dewan MC, Kulkarni AV, Schiff SJ, Warf B. The Incidence of Postoperative Seizures Following Treatment of Postinfectious Hydrocephalus in Ugandan Infants: A Post Hoc Comparison of Endoscopic Treatment vs Shunt Placement in a Randomized Controlled Trial. Neurosurgery. 2019 Oct 1;85(4):E714-E721. doi: 10.1093/neuros/nyz122.
PubMed 31086941Kulkarni AV, Schiff SJ, Mbabazi-Kabachelor E, Mugamba J, Ssenyonga P, Donnelly R, Levenbach J, Monga V, Peterson M, MacDonald M, Cherukuri V, Warf BC. Endoscopic Treatment versus Shunting for Infant Hydrocephalus in Uganda. N Engl J Med. 2017 Dec 21;377(25):2456-2464. doi: 10.1056/NEJMoa1707568.
PubMed 29262276
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Outcomes and Changes in Brain and Cerebral Spinal Fluid (CSF) Volume After Treatment of Post-Infectious Hydrocephalus (PIH) in Ugandan Infants by Shunting Versus ETV/CPC
- ClinicalTrials.gov ID
- NCT01936272
- Acronym / sponsor ID
- P00002785
- Conditions
- Hydrocephalus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Penn State University, The Hospital for Sick Children, CURE Children's Hospital, Uganda
- Study start
- 27 May 2013 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 6 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Two treatment options exist for infant patients with hydrocephalus. Most patients are treated with a surgical procedure in which a shunt is inserted into the brain and abdomen. In recent years, however, another treatment has developed called Endoscopic Third Ventriculostomy (ETV) with Choroid Plexus Cauterization (ETV/CPC).This research study is being done to measure the results of these procedures in children less than six months of age who have hydrocephalus as the result of a brain infection, called post-infectious hydrocephalus, or PIH. This study will evaluate patients in more detail to measure brain growth and development.
Detailed description
World over, infants with hydrocephalus are mainly treated using a shunt, which is a device made of soft plastic tubing that moves extra fluid from the brain to the abdomen. Surgery is required to insert a shunt into the brain and the abdomen. In recent years, we have developed another treatment called Endoscopic Third Ventriculostomy (ETV) with Choroid Plexus Cauterization (ETV/CPC). This research study is being done to measure the results of these procedures in children less than six months of age who have hydrocephalus as the result of a brain infection, called post-infectious hydrocephalus, or PIH. This is the most common cause of hydrocephalus in Ugandan babies. This study will evaluate patients in more detail to measure brain growth and development. Children in the study will have special testing to measure developmental progress as well as special imaging to evaluate the progress of their brain growth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chhabra Shunt Placement | Active comparator | Device: Chhabra Shunt PlacementThe shunting arm will comprise a standard frontal approach ventriculoperitoneal shunt using a silastic Chhabra system. |
| ETV/CPC | Active comparator | Procedure: ETV/CPCThe Endoscopic Third Ventriculostomy/Choroid Plexus Cauterization (ETV/CPC) arm will comprise a standard frontal approach with flexible endoscopy. |
Who may qualify
- Ages
- 1 day to 180 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants less than 180 days (six months) old
- Symptomatic hydrocephalus
- Post-infectious Hydrocephalus based on clinical and CT parameters2
- Must be from the following Ugandan districts: Bugiri, Busia, Iganga, Jinja, Kampala, Kamuli, Kapchorwa, Katakwi, Kumi, Mayuge, Mbale, Mukono, Pallisa, Sironko, Soroti, and Tororo
Key exclusion criteria (4 listed)
- Any patient with a scalp erosion or infection that would exclude the patient from shunt implantation
- Any patient with ventricular loculations that would normally indicate the use of ventriculoscopy as an adjunct to shunt placement
- Any patient with absence of any visible cortical mantle on the CT
- Patients must be appropriate candidates for either surgical procedure - shunt placement alone or ETV/CPC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chhabra Shunt Placement | Device | Chhabra Shunt Placement |
| ETV/CPC | Procedure or surgery | ETV/CPC |
Primary outcome
Change of Age-normed Bayley Scales of Infant Development (BSID)-III scores
Time frame: 12 months and 24 months post treatment
Neurocognition will be measured using the BSID-III Cognitive Scale. Change will be assessed at 24 months post treatment from baseline score (12 months post treatment).
3 secondary outcomes
Brain Volume
Time frame: 12 months, 24 months, 5 years, and 7-10 years post treatment
CSF Volume
Time frame: 12 months, 24 months, 5 years, and 7-10 years post treatment
Vineland Adaptive Behavior Scales
Time frame: 5 years and 7-10 years post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Derived from this study: PubMed 42757834Rattani A, Spencer JC, Agwu CK, Dewan MC, Kabachelor EM, Ssenyonga P, Mugamba J, Schiff SJ, Kulkarni AV, Warf BC. Five-Year Cost-Effectiveness Analysis of Endoscopic Third Ventriculostomy With Choroid Plexus Cauterization Versus Ventriculoperitoneal Shunting in Postinfectious Hydrocephalus in a Low-Income Setting. Neurosurgery. 2026 Sep 18. doi: 10.1227/neu.0000000000004218. Online ahead of print.
- Derived from this study: PubMed 40489263Mukherjee S, Templeton K, Tindimwebwa S, Lin PY, Sutin J, Yu M, Peterson M, Truwit C, Schiff SJ, Monga V. GLAPAL-H: Global, Local, and Parts Aware Learner for Hydrocephalus Infection Diagnosis in Low-Field MRI. IEEE Trans Biomed Eng. 2026 Jan;73(1):139-152. doi: 10.1109/TBME.2025.3578541.
- Derived from this study: PubMed 34911199Harper JR, Cherukuri V, O'Reilly T, Yu M, Mbabazi-Kabachelor E, Mulando R, Sheth KN, Webb AG, Warf BC, Kulkarni AV, Monga V, Schiff SJ. Assessing the utility of low resolution brain imaging: treatment of infant hydrocephalus. Neuroimage Clin. 2021;32:102896. doi: 10.1016/j.nicl.2021.102896. Epub 2021 Nov 23.
- Derived from this study: PubMed 31086941Punchak M, Mbabazi Kabachelor E, Ogwal M, Nalule E, Nalwoga J, Ssenyonga P, Mugamba J, Rattani A, Dewan MC, Kulkarni AV, Schiff SJ, Warf B. The Incidence of Postoperative Seizures Following Treatment of Postinfectious Hydrocephalus in Ugandan Infants: A Post Hoc Comparison of Endoscopic Treatment vs Shunt Placement in a Randomized Controlled Trial. Neurosurgery. 2019 Oct 1;85(4):E714-E721. doi: 10.1093/neuros/nyz122.
- Derived from this study: PubMed 29262276Kulkarni AV, Schiff SJ, Mbabazi-Kabachelor E, Mugamba J, Ssenyonga P, Donnelly R, Levenbach J, Monga V, Peterson M, MacDonald M, Cherukuri V, Warf BC. Endoscopic Treatment versus Shunting for Infant Hydrocephalus in Uganda. N Engl J Med. 2017 Dec 21;377(25):2456-2464. doi: 10.1056/NEJMoa1707568.
- Individual participant dataSharing planned: No. IPD will not be shared with researchers outside of the study team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin C Warf, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chhabra Shunt Placement and ETV/CPC in people with Hydrocephalus, run by Boston Children's Hospital at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Age-normed Bayley Scales of Infant Development (BSID)-III scores (time frame: 12 months and 24 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01936272, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.