search
Back to results

A Study Comparing Two Treatments for Infants With Hydrocephalus

Primary Purpose

Hydrocephalus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Endoscopic Third Ventriculostomy
CSF Shunt Insertion
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hydrocephalus focused on measuring infants, Hydrocephalus, Cerebrospinal Fluid Shunt, Ventriculostomy, neurosurgery

Eligibility Criteria

1 Day - 24 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Children's Medical Center of Dallas
  • Nacional de Pediatria
  • Biocor Instituto
  • UNIFESP
  • The Hospital for Sick Children
  • University Hospital Gießen and Marburg
  • University of Debrecen
  • Sanjay Gandhi Postgraduate Institute of Medical Sciences
  • All India Institute of Medical Sciences
  • Dana Children's Hospital, Tel Aviv Medical Center
  • Giannina Gaslini Hospital
  • Catholic University Medical School Rome
  • University Medical Center St Radboud
  • Medical University of Silesia
  • Polish Mother's Memorial Hospital
  • Children's Memorial Health Institute
  • Burdenko Neurosurgical Institute
  • Institute for Neurosurgery
  • Hospital Sant Joan de Deu
  • Hacettepe University Hospital
  • Birmingham Children's Hospital
  • Alder Hey Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ETV

CSF Shunt

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Death
Neurodevelopment as measured by the Denver Developmental Screening Test
Health status outcome using the Hydrocephalus Outcome Questionnaire
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
Number of Subsequent Hydrocephalus-Related Operations
Surgical Morbidity
Incidence of failure of initial intervention
Hospitalization Time
Need for repeat radiological scans
Complications such as CNS infection, focal neurological deficit, significant hemorrhage, seizures requiring medication
Ventricular size and the existence of flow void (ETV group)assessed through radiological evaluation

Full Information

First Posted
March 31, 2008
Last Updated
September 7, 2018
Sponsor
The Hospital for Sick Children
Collaborators
The International Study Group for Neuroendoscopy (ISGNE), The International Society for Pediatric Neurosurgery
search

1. Study Identification

Unique Protocol Identification Number
NCT00652470
Brief Title
A Study Comparing Two Treatments for Infants With Hydrocephalus
Official Title
International Infant Hydrocephalus Study: A Multicentre, Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
The International Study Group for Neuroendoscopy (ISGNE), The International Society for Pediatric Neurosurgery

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
TVH is a relatively uncommon condition in infants, in which CSF accumulates in the brain's ventricles due to a blockage in outflow at the level of cerebral aqueduct. This can cause increased intracranial pressure, with adverse effect on brain development. The causes of this include congenital aqueductal stensois or acquired aqueductal stenosis from previous brain hemorrhage or infection. TVH is currently treated through one of the following two approaches: Extra-cranial CSF diversion through ventricular shunts. Extra-cranial shunting has been the standard approach over the past few decades, since functional shunts were first developed and inserted successfully. Intra-cranial internal CSF diversion using endoscopic techniques. The principles of internal diversion were clear from the time neurosurgeons first understood the nature of hydrocephalus. However, internal diversion was never really practical or successful on a large scale until the more recent development of neuroendoscopy. There is currently a revived interest in diversionary hydrocephalus treatment through neuroendoscopic surgical techniques, with the primary focus on endoscopic third ventriculostomy (ETV).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydrocephalus
Keywords
infants, Hydrocephalus, Cerebrospinal Fluid Shunt, Ventriculostomy, neurosurgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ETV
Arm Type
Active Comparator
Arm Title
CSF Shunt
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Third Ventriculostomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
CSF Shunt Insertion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Health Status Outcome as measured by the Health Utilities Index - 2
Time Frame
At 5 years of age
Secondary Outcome Measure Information:
Title
Death
Time Frame
Duration of the Study
Title
Neurodevelopment as measured by the Denver Developmental Screening Test
Time Frame
Up to 3 years of Age
Title
Health status outcome using the Hydrocephalus Outcome Questionnaire
Time Frame
At 5 years of Age
Title
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
Time Frame
At 5 years of Age
Title
Number of Subsequent Hydrocephalus-Related Operations
Time Frame
Duration of the Study
Title
Surgical Morbidity
Time Frame
Duration of the Study
Title
Incidence of failure of initial intervention
Time Frame
Duration of the Study
Title
Hospitalization Time
Time Frame
5 years post-operation
Title
Need for repeat radiological scans
Time Frame
Duration of the Study
Title
Complications such as CNS infection, focal neurological deficit, significant hemorrhage, seizures requiring medication
Time Frame
Duration of the Study
Title
Ventricular size and the existence of flow void (ETV group)assessed through radiological evaluation
Time Frame
3 years of age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abhaya Kulkarni, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shlomi Constantini, MD
Organizational Affiliation
Dana Children's Hospital, Tel Aviv Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Spyros Sgouros, MD
Organizational Affiliation
Birmingham Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Medical Center of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Nacional de Pediatria
City
Buenos Aires
Country
Argentina
Facility Name
Biocor Instituto
City
Nova Lima
Country
Brazil
Facility Name
UNIFESP
City
Sao Paulo
Country
Brazil
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
University Hospital Gießen and Marburg
City
Giessen
Country
Germany
Facility Name
University of Debrecen
City
Debrecen
Country
Hungary
Facility Name
Sanjay Gandhi Postgraduate Institute of Medical Sciences
City
Lucknow
Country
India
Facility Name
All India Institute of Medical Sciences
City
New Delhi
Country
India
Facility Name
Dana Children's Hospital, Tel Aviv Medical Center
City
Tel Aviv
Country
Israel
Facility Name
Giannina Gaslini Hospital
City
Genova
Country
Italy
Facility Name
Catholic University Medical School Rome
City
Rome
Country
Italy
Facility Name
University Medical Center St Radboud
City
Nijmegen
Country
Netherlands
Facility Name
Medical University of Silesia
City
Katowice
Country
Poland
Facility Name
Polish Mother's Memorial Hospital
City
Lodz
Country
Poland
Facility Name
Children's Memorial Health Institute
City
Warsaw
Country
Poland
Facility Name
Burdenko Neurosurgical Institute
City
Moscow
Country
Russian Federation
Facility Name
Institute for Neurosurgery
City
Belgrade
Country
Serbia
Facility Name
Hospital Sant Joan de Deu
City
Barcelona
Country
Spain
Facility Name
Hacettepe University Hospital
City
Ankara
Country
Turkey
Facility Name
Birmingham Children's Hospital
City
Birmingham
Country
United Kingdom
Facility Name
Alder Hey Children's Hospital
City
Liverpool
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29987375
Citation
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.
Results Reference
derived
PubMed Identifier
28357554
Citation
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.
Results Reference
derived
PubMed Identifier
27107887
Citation
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.
Results Reference
derived

Learn more about this trial

A Study Comparing Two Treatments for Infants With Hydrocephalus

We'll reach out to this number within 24 hrs