A Study Comparing Two Treatments for Infants With Hydrocephalus

NCT00652470 | Completed Phase 2 DMC

• 1 other identifier: 1000007601
• Study Type: interventional
• Target: 182
• Locations: 16 countries
• Sites: 22

Brief Summary

The purpose of this study is to study whether infants with triventricular hydrocephalus (TVH) have a better long-term outcome at 5 years when they are treated with a new procedure, endoscopic third ventriculostomy (ETV), than infants treated with the more traditional treatment, insertion of a cerebrospinal fluid (CSF) shunt.

Conditions

Hydrocephalus

Keywords

infants; Hydrocephalus; Cerebrospinal Fluid Shunt; Ventriculostomy; neurosurgery

Outcome Measures

Primary Outcomes (1)

• Health Status Outcome as measured by the Health Utilities Index - 2

  At 5 years of age

Secondary Outcomes (11)

• Death

  Duration of the Study

• Neurodevelopment as measured by the Denver Developmental Screening Test

  Up to 3 years of Age

• Health status outcome using the Hydrocephalus Outcome Questionnaire

  At 5 years of Age

• In-depth Evaluation of Neurodevelopment, Functioning and Intelligence, as mesured by the Weschler Intelligence Scale for Children or Weschler Preschool and Primary Scale of Intelligence

  At 5 years of Age

• Number of Subsequent Hydrocephalus-Related Operations

  Duration of the Study

Study Arms (2)

ETV

ACTIVE COMPARATOR

Procedure: Endoscopic Third Ventriculostomy

CSF Shunt

ACTIVE COMPARATOR

Procedure: CSF Shunt Insertion

Interventions

Endoscopic Third Ventriculostomy PROCEDURE

A standard frontal burr hole will be made and an endoscopic camera used to visualize the floor of the third ventricle. A ventriculostomy will be created in the floor of the third using the surgeon's own preferred method of perforation.

ETV

CSF Shunt Insertion PROCEDURE

The procedure involves creating a burr hole in the frontal or occipital regions and cannulating the ventricle with a silastic catheter. This is then attached to a valve mechanism and distal silastic tubing which runs subcutaneously in the peritoneal cavity.

CSF Shunt

Eligibility Criteria

• Age: 1 Day - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Symptomatic TVH requiring treatment.
• No previous treatment for TVH
• Under 24 months of age at time of surgery
• Full-term pregnancy (\>36 weeks)
• Mandatory pre-operative MRI that includes mid-sagittal T1 \& T2 scans which show: Tri-ventricular pattern of hydrocephalus; proof of no flow through aqueduct; presence of CSF collection over the convexity and/or inter-hemispheric fissure is acceptable; configuration of third ventricle floor could vary; deformed tectal plate is acceptable; posterior fossa fluid collections may be included as long as: aqueduct is closed; vermis preserved (complete Dandy Walker Syndrome excluded); questionable flow in aqueduct acceptable as long as TVH exists
• History or suggestion of intra-ventricular bleed (intra-uterine or post-natal) or intracranial infection qualifies (excluding intraventricular hemorrhage of prematurity).
• Ability to participate in followup for at least 5 years

You may not qualify if:

• Open Spina Bifida
• Complete Dandy Walker syndrome (vermian agenesis / dysgenesis)
• Prematurity
• Perinatal asphyxia
• Severe dysmorphic anatomical features or known chromos (e.g. agenesis of corpus callosum, heterotopias, large cysts)
• intracranial tumor

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• The International Study Group for Neuroendoscopy (ISGNE): collaborator
• The International Society for Pediatric Neurosurgery: collaborator

Study Sites (22)

Children's Medical Center of Dallas

Dallas, Texas, 75235, United States

Location

Nacional de Pediatria

Buenos Aires, Argentina

Location

Biocor Instituto

Nova Lima, Brazil

Location

UNIFESP

São Paulo, Brazil

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

University Hospital Gießen and Marburg

Giessen, Germany

Location

University of Debrecen

Debrecen, Hungary

Location

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Lucknow, India

Location

All India Institute of Medical Sciences

New Delhi, India

Location

Dana Children's Hospital, Tel Aviv Medical Center

Tel Aviv, Israel

Location

Giannina Gaslini Hospital

Genova, Italy

Location

Catholic University Medical School Rome

Rome, Italy

Location

University Medical Center St Radboud

Nijmegen, Netherlands

Location

Medical University of Silesia

Katowice, Poland

Location

Polish Mother's Memorial Hospital

Lodz, Poland

Location

Children's Memorial Health Institute

Warsaw, Poland

Location

Burdenko Neurosurgical Institute

Moscow, Russia

Location

Institute for Neurosurgery

Belgrade, Serbia

Location

Hospital Sant Joan de Deu

Barcelona, Spain

Location

Hacettepe University Hospital

Ankara, Turkey (Türkiye)

Location

Birmingham Children's Hospital

Birmingham, United Kingdom

Location

Alder Hey Children's Hospital

Liverpool, United Kingdom

Location

Related Publications (3)

• Kulkarni AV, Sgouros S, Leitner Y, Constantini S; International Infant Hydrocephalus Study Investigators. International Infant Hydrocephalus Study (IIHS): 5-year health outcome results of a prospective, multicenter comparison of endoscopic third ventriculostomy (ETV) and shunt for infant hydrocephalus. Childs Nerv Syst. 2018 Dec;34(12):2391-2397. doi: 10.1007/s00381-018-3896-5. Epub 2018 Jul 9.

  PMID: 29987375 DERIVED

• Kulkarni AV, Sgouros S, Constantini S; International Infant Hydrocephalus Study Investigators. Outcome of treatment after failed endoscopic third ventriculostomy (ETV) in infants with aqueductal stenosis: results from the International Infant Hydrocephalus Study (IIHS). Childs Nerv Syst. 2017 May;33(5):747-752. doi: 10.1007/s00381-017-3382-5. Epub 2017 Mar 29.

  PMID: 28357554 DERIVED

• Kulkarni AV, Sgouros S, Constantini S; IIHS Investigators. International Infant Hydrocephalus Study: initial results of a prospective, multicenter comparison of endoscopic third ventriculostomy (ETV) and shunt for infant hydrocephalus. Childs Nerv Syst. 2016 Jun;32(6):1039-48. doi: 10.1007/s00381-016-3095-1. Epub 2016 Apr 23.

  PMID: 27107887 DERIVED

MeSH Terms

Conditions

Hydrocephalus

Interventions

Ventriculostomy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cerebrospinal Fluid Shunts; Anastomosis, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• Abhaya Kulkarni, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

• Shlomi Constantini, MD

  Dana Children's Hospital, Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

• Spyros Sgouros, MD

  Birmingham Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff neurosurgeon

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 3, 2008
• Study Start: September 1, 2005
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: September 10, 2018

Record last verified: 2018-09

Locations

IL (1); US (1); CA (1); BR (2); PL (3); RU (1); NL (1); SE (1); IN (2); IT (2); ES (1); TU (1); GB (2); AR (1); HU (1); DE (1)