Randomized Controlled Trial of Shunt vs ETV/CPC for PIH in Ugandan Infants

NCT01936272 | Unknown Phase 3 DMC

• 1 other identifier: P00002785
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydrocephalus

Outcome Measures

Primary Outcomes (1)

• 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).

  12 months and 24 months post treatment

Secondary Outcomes (3)

• Brain Volume

  12 months, 24 months, 5 years, and 7-10 years post treatment

• CSF Volume

  12 months, 24 months, 5 years, and 7-10 years post treatment

• Vineland Adaptive Behavior Scales

  5 years and 7-10 years post treatment

Study Arms (2)

Chhabra Shunt Placement

ACTIVE COMPARATOR

The shunting arm will comprise a standard frontal approach ventriculoperitoneal shunt using a silastic Chhabra system.

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.

Procedure: ETV/CPC

Interventions

Chhabra Shunt Placement DEVICE

Chhabra Shunt Placement

ETV/CPC PROCEDURE

ETV/CPC

Eligibility Criteria

• Age: 1 Day - 180 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Penn State University: collaborator
• The Hospital for Sick Children: collaborator
• CURE Children's Hospital, Uganda: collaborator

Study Sites (1)

CURE Children's Hospital Uganda

Mbale, Uganda

Location

Related Publications (3)

• 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.

  PMID: 34911199 DERIVED

• 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.

  PMID: 31086941 DERIVED

• 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.

  PMID: 29262276 DERIVED

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Benjamin C Warf, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurosurgery, Hydrocephalus and Spina Bifida Chair

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: September 6, 2013
• Study Start: May 27, 2013
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)