Clinical trial NCT01936272: Randomized Controlled Trial of Shunt vs ETV/CPC for PIH in Ugandan Infants
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Hydrocephalus
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Penn State University
name: The Hospital for Sick Children
name: CURE Children's Hospital, Uganda
First posted: 2013-09-06
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 180
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 (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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of Age-normed Bayley Scales of Infant Development (BSID)-III scores
timeFrame: 12 months and 24 months post treatment
Secondary outcomes:
measure: Brain Volume
timeFrame: 12 months, 24 months, 5 years, and 7-10 years post treatment
measure: CSF Volume
timeFrame: 12 months, 24 months, 5 years, and 7-10 years post treatment
measure: Vineland Adaptive Behavior Scales
timeFrame: 5 years and 7-10 years post treatment
Other outcomes:
Locations:
city: Mbale
country: Uganda
facility: CURE Children's Hospital Uganda
Study officials:
affiliation: Boston Children's Hospital
name: Benjamin C Warf, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harper 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.
citation: Punchak 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.
citation: Kulkarni 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.