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HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants (ESTHI)

Primary Purpose

Hydrocephalus

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC)
Ventriculoperitoneal Shunt
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hydrocephalus focused on measuring Hydrocephalus, Infants, Ventriculoperitoneal Shunt, ETV+CPC, endoscopic third ventriculostomy, choroid plexus cauterization

Eligibility Criteria

0 Days - 104 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Corrected age <104 weeks and 0 days,

    AND

  2. Child is ≥ 37 weeks post menstrual age,

    AND

  3. Child must have symptomatic hydrocephalus, defined as:

    Ventriculomegaly on MRI (frontal-occipital horn ratio (FOR) >0.45, which approximates "moderate ventriculomegaly"), and at least one of the following:

    • Head circumference >98th percentile for corrected age with either bulging fontanelle or splayed sutures
    • Upgaze paresis/palsy (sundowning)
    • CSF leak
    • Papilledema
    • Tense pseudomeningocele or tense fluid along a track
    • Vomiting or irritability, with no other attributable cause
    • Bradycardias or apneas, with no other attributable cause
    • Intracranial pressure (ICP) monitoring showing persistent elevation of pressure with or without plateau waves

    AND

  4. No prior history of shunt insertion or endoscopic third ventriculostomy (ETV) procedure (previous temporization devices and/or external ventricular drains permissible)

Exclusion Criteria:

  1. Hydrocephalus due to intraventricular hemorrhage in a child born before 37 weeks gestational age; OR

  2. Anatomy not suitable for ETV+CPC or anteriorly placed ventriculoperitoneal shunt defined as:

    • Moderate to severe prepontine adhesions on steady state free precession (SSFP) or T2 weighted fast (turbo) spin echo (FSE/TSE) MRI, which includes the following sequences: FIESTA, FIESTA-C, TrueFISP, CISS, Balanced FFE (bFFE), CUBE, SPACE, VISTA, IsoFSE, and 3D MVOX
    • Closure of one or both foramina of Monro
    • Thick floor of third ventricle (≥ 3mm)
    • Narrow third ventricle (<5mm)
    • Presence of scalp, bone, or ventricular lesions that make placement of an anterior shunt impracticable; OR
  3. Underlying condition with a high chance of mortality within 12 months; OR
  4. Hydrocephalus with loculated CSF compartments; OR
  5. Peritoneal cavity not suitable for distal shunt placement; OR
  6. Active CSF infection; OR
  7. Hydranencephaly; OR
  8. Child requires an intraventricular procedure (e.g. endoscopic biopsy) in addition to the initial first-time permanent procedure for the treatment of hydrocephalus.

Sites / Locations

  • Children's of AlabamaRecruiting
  • Children's Hospital of Los AngelesRecruiting
  • Children's Hospital ColoradoRecruiting
  • Wolfson Children's HospitalRecruiting
  • Arnold Palmer Hospital for ChildrenRecruiting
  • Johns Hopkins Children's CenterRecruiting
  • St. Louis Children's HospitalRecruiting
  • Nationwide Children's HospitalRecruiting
  • Children's Hospital of Pittsburgh of UPMCRecruiting
  • The Pennsylvania State University
  • Monroe Carell Jr. Children's Hospital at VanderbiltRecruiting
  • Texas Children's HospitalRecruiting
  • Primary Children's HospitalRecruiting
  • Seattle Children's HospitalRecruiting
  • Alberta Children's HospitalRecruiting
  • British Columbia Children's HospitalRecruiting
  • The Hospital for Sick ChildrenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ETV+CPC

Ventriculoperitoneal Shunt

Arm Description

Subjects randomized to this arm will undergo an ETV+CPC procedure for treatment of Hydrocephalus

Subjects randomized to this arm will undergo a Ventriculoperitoneal Shunt procedure for treatment of Hydrocephalus

Outcomes

Primary Outcome Measures

Bayley Scale of Infant Development-IV (Bayley-IV) Cognitive Scale score
The primary objective is to determine, in infants <104 weeks corrected age, with hydrocephalus requiring treatment at tertiary care pediatric neurosurgery centers in North America, if treatment with ETV+CPC compared to shunt results in non-inferior cognitive outcome at 12 months from surgery, as measured by Bayley-IV Cognitive Scale score with a non-inferiority margin of 1.5. Scaled scores range from 1-19. Higher scores indicate better outcomes. Scores will also be obtained at 3 and 5 years of age.

Secondary Outcome Measures

Bayley Scale of Infant Development-IV (Bayley-IV) Language Scaled Score
To determine, in the same cohort of infants, if ETV+CPC compared to shunt results in non-inferior Bayley-IV Language Scaled scores. Scaled scores range from 1-19. Higher scores indicate better outcomes.
Bayley Scale of Infant Development-IV (Bayley-IV) Motor Scaled Score
To determine, in the same cohort of infants, if ETV+CPC compared to shunt results in non-inferior Bayley-IV Motor Scaled scores. Scaled scores range from 1-19. Higher scores indicate better outcomes.

Full Information

First Posted
October 27, 2019
Last Updated
August 30, 2023
Sponsor
University of Utah
Collaborators
University of Alabama at Birmingham, University of British Columbia, University of Pittsburgh, The Hospital for Sick Children, Seattle Children's Hospital, Vanderbilt University Medical Center, Washington University School of Medicine, Nationwide Children's Hospital, Johns Hopkins University, University of Calgary, University of Colorado, Denver, Children's Hospital Los Angeles, National Institutes of Health (NIH), Hydrocephalus Association, Penn State University, National Institute of Neurological Disorders and Stroke (NINDS), Baylor College of Medicine, University of Florida, Orlando Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04177914
Brief Title
HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
Acronym
ESTHI
Official Title
Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
University of Alabama at Birmingham, University of British Columbia, University of Pittsburgh, The Hospital for Sick Children, Seattle Children's Hospital, Vanderbilt University Medical Center, Washington University School of Medicine, Nationwide Children's Hospital, Johns Hopkins University, University of Calgary, University of Colorado, Denver, Children's Hospital Los Angeles, National Institutes of Health (NIH), Hydrocephalus Association, Penn State University, National Institute of Neurological Disorders and Stroke (NINDS), Baylor College of Medicine, University of Florida, Orlando Health, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Hydrocephalus is a potentially debilitating neurological condition that primarily affects babies under a year of age and has traditionally been treated by inserting a shunt between the brain and the abdomen. A newer endoscopic procedure offers hope of shunt- free treatment that may reduce complications over a child's life, but it is not clear if the endoscopic procedure results in similar intellectual outcome as shunt. Therefore, the investigators propose a randomized trial to compare intellectual outcome and brain structural integrity between these two treatments, to help families make the best treatment decision for their baby.
Detailed Description
The ESTHI Trial is a multi-center randomized controlled trial (RCT) comparing endoscopic third ventriculostomy with choroid plexus cauterization (ETV+CPC) and shunt in infants with hydrocephalus. The study will leverage the infrastructure of the Hydrocephalus Clinical Research Network (HCRN), a committed group of 14 leading North American pediatric neurosurgical centers with a long track-record of successful collaborative clinical research and RCTs in hydrocephalus. Optimal cognitive outcome is the primary concern of families and will, therefore, be the primary outcome. Assessment of dMRI, a validated, non-invasive method of measuring white matter microstructural integrity and structural connectivity in the developing brain, will provide further insight into the developmental consequences of these two treatments. The results of the RCT will help families determine the optimal treatment of hydrocephalus for their child.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydrocephalus
Keywords
Hydrocephalus, Infants, Ventriculoperitoneal Shunt, ETV+CPC, endoscopic third ventriculostomy, choroid plexus cauterization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
176 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ETV+CPC
Arm Type
Active Comparator
Arm Description
Subjects randomized to this arm will undergo an ETV+CPC procedure for treatment of Hydrocephalus
Arm Title
Ventriculoperitoneal Shunt
Arm Type
Active Comparator
Arm Description
Subjects randomized to this arm will undergo a Ventriculoperitoneal Shunt procedure for treatment of Hydrocephalus
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC)
Intervention Description
Since the early 1990s, ETV has become the main alternative to shunting for hydrocephalus. This procedure involves placing an endoscopic camera into the ventricles of the brain and creating a hole in the floor of the third ventricle to act as an internal bypass for obstructed CSF. The cauterization of choroid plexus (CPC) involves the use of a device to burn or cauterize tissue from the choroid plexus. The choroid plexus of the brain exists in the lateral ventricles, the third ventricle, and the fourth ventricle. Its main role is the production of CSF. The success of ETV alone is poor in infants, but when combined with CPC, improved results have been observed and ETV+CPC has become a safe viable option for these children.
Intervention Type
Device
Intervention Name(s)
Ventriculoperitoneal Shunt
Intervention Description
The most common treatment for hydrocephalus has been the insertion of a ventriculoperitoneal shunt, which has been in popular use for over 50 years. This consists of silastic tubing attached to a valve mechanism that runs subcutaneously from the head to the abdomen. It is one of the most common procedures performed by pediatric neurosurgeons.
Primary Outcome Measure Information:
Title
Bayley Scale of Infant Development-IV (Bayley-IV) Cognitive Scale score
Description
The primary objective is to determine, in infants <104 weeks corrected age, with hydrocephalus requiring treatment at tertiary care pediatric neurosurgery centers in North America, if treatment with ETV+CPC compared to shunt results in non-inferior cognitive outcome at 12 months from surgery, as measured by Bayley-IV Cognitive Scale score with a non-inferiority margin of 1.5. Scaled scores range from 1-19. Higher scores indicate better outcomes. Scores will also be obtained at 3 and 5 years of age.
Time Frame
12 months post randomized surgical intervention
Secondary Outcome Measure Information:
Title
Bayley Scale of Infant Development-IV (Bayley-IV) Language Scaled Score
Description
To determine, in the same cohort of infants, if ETV+CPC compared to shunt results in non-inferior Bayley-IV Language Scaled scores. Scaled scores range from 1-19. Higher scores indicate better outcomes.
Time Frame
12 months post randomized surgical intervention
Title
Bayley Scale of Infant Development-IV (Bayley-IV) Motor Scaled Score
Description
To determine, in the same cohort of infants, if ETV+CPC compared to shunt results in non-inferior Bayley-IV Motor Scaled scores. Scaled scores range from 1-19. Higher scores indicate better outcomes.
Time Frame
12 months post randomized surgical intervention
Other Pre-specified Outcome Measures:
Title
Vineland-3 Communication Domain Score
Description
To determine, in the same cohort of infants, if ETV+CPC compared to shunt results in non-inferior Vineland-3 Communication Domain scores. Domain scores range from 20-140. Higher scores indicate better outcomes.
Time Frame
12 months post randomized surgical intervention
Title
Vineland-3 Daily Living Skills Domain Score
Description
To determine, in the same cohort of infants, if ETV+CPC compared to shunt results in non-inferior Vineland-3 Daily Living Skills Domain scores. Domain scores range from 20-140. Higher scores indicate better outcomes.
Time Frame
12 months post randomized surgical intervention
Title
Vineland-3 Socialization Domain Score
Description
To determine, in the same cohort of infants, if ETV+CPC compared to shunt results in non-inferior Vineland-3 Socialization Domain scores. Domain scores range from 20-140. Higher scores indicate better outcomes.
Time Frame
12 months post randomized surgical intervention
Title
Vineland-3 Motor Skills Domain Score
Description
To determine, in the same cohort of infants, if ETV+CPC compared to shunt results in non-inferior Vineland-3 Motor Skills Domain scores. Domain scores range from 20-140. Higher scores indicate better outcomes.
Time Frame
12 months post randomized surgical intervention
Title
Vineland-3 Adaptive Behavior Composite Score
Description
To determine, in the same cohort of infants, if ETV+CPC compared to shunt results in non-inferior Vineland-3 Adaptive Behavior Composite (ABC) scores. ABC scores range from 20-140. Higher scores indicate better outcomes.
Time Frame
12 months post randomized surgical intervention
Title
The occurrence of treatment failure.
Description
Treatment failure is defined as obstruction, loculated compartments, overdrainage, CSF infection, or significant intraoperative complication. The rate of occurrence of each type, for the initial procedure, will be calculated. Failure can be captured at anytime during the course of the 7 year study. Occurrence between treatment arms will be compared.
Time Frame
Through study completion, a maximum of 7 years.
Title
Time to failure.
Description
Time to failure is the number of days in which the intervention is functionally successful. It is calculated from date of surgery to date of failure, as described in Outcome 9. Time to failure between treatment arms will be compared.
Time Frame
Through study completion, a maximum of 7 years
Title
Total number of hospital admission days within 12 months after surgery
Description
Number of days subject is admitted to the hospital during the first 12 months following the initial surgical intervention. All hospital admissions included, regardless of reason for admission. Number of hospital admission days between treatment arms will be compared.
Time Frame
12 months post randomized surgical intervention
Title
Total number of repeat surgeries within 12 months after surgery
Description
Number of shunt and ETV+CPC procedures during the first 12 months following the initial surgical intervention. Number of repeat surgeries between treatment arms will be compared.
Time Frame
12 months post randomized surgical intervention
Title
Total number of brain imaging (CT, MRI, ultrasound) scans within 12 months after surgery
Description
Number of CT, MRI, and ultrasound brain scans during the first 12 months following the initial surgical intervention. Total imaging between treatment arms will be compared.
Time Frame
12 months post randomized surgical intervention
Title
All major peri-operative and post-operative complications
Description
Number of peri-operative and post-operative complications to include those related to CSF circulation, infection, hemorrhage, seizures, and new neurological deficits. Number of complications between treatment arms will be compared.
Time Frame
Through study completion, a maximum of 7 years
Title
Brain and ventricle volume on MRI performed at 12 months after surgery
Description
Brain and CSF volumes will be converted to Z-scores based on previously described age- and sex-adjusted distributions and used for comparison of brain volume and growth between ETV+CPC and shunt treatment groups.
Time Frame
12 months post randomized surgical intervention
Title
dMRI corpus collosum (CC) and corticospinal tract (CST) fractional anisotropy (FA) at 12 months after surgery.
Description
Develop dMRI maps, including fractional anisotropy (FA), mean diffusivity (MD), axial diffusivity (AD), and radial diffusivity (RD). Tract-based spatial statistics (TBSS) will be used for voxel-wise analyses of white matter tracts. Maps will be used to compare cerebral structural connectivity between the two treatment arms.
Time Frame
12 months post randomized surgical intervention
Title
Cerebral spinal fluid myelin basic protein (MBP) levels measured at the time of ETV+CPC or shunt
Description
Examine correlations of cerebral spinal fluid myelin basic protein (MBP) levels to post-operative Bayley-IV Cognitive Scale score.
Time Frame
12 months post randomized surgical intervention
Title
Cerebral spinal fluid amyloid precursor protein (APP) levels measured at the time of ETV+CPC or shunt
Description
Examine correlations of cerebral spinal fluid amyloid precursor protein (APP) to post-operative Bayley-IV Cognitive Scale score
Time Frame
12 months post randomized surgical intervention
Title
Cerebral spinal fluid NCAM-1 levels measured at the time of ETV+CPC or shunt
Description
Examine correlations of cerebral spinal fluid NCAM-1 levels to post-operative Bayley-IV Cognitive Scale score
Time Frame
12 months post randomized surgical intervention
Title
Cerebral spinal fluid glial fibrillary acid protein (GFAP) levels measured at the time of ETV+CPC or shunt
Description
Examine correlations of cerebral spinal fluid glial fibrillary acid protein (GFAP) to post-operative Bayley-IV Cognitive Scale score
Time Frame
12 months post randomized surgical intervention
Title
Wechsler Preschool & Primary Scale of Intelligence (WPPSI) Scores
Description
To determine, in infants who reach 5 years of age before the end of the study, if ETV+CPC compared to shunt results in non-inferior WPPSI scaled scores. Scaled scores range from 1-19. Higher scores indicate better outcomes.
Time Frame
At 5 years of age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
104 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Corrected age <104 weeks and 0 days, AND Child is ≥ 37 weeks post menstrual age, AND Child must have symptomatic hydrocephalus, defined as: Ventriculomegaly on MRI (frontal-occipital horn ratio (FOR) >0.45, which approximates "moderate ventriculomegaly"), and at least one of the following: Head circumference >98th percentile for corrected age with either bulging fontanelle or splayed sutures Upgaze paresis/palsy (sundowning) CSF leak Papilledema Tense pseudomeningocele or tense fluid along a track Vomiting or irritability, with no other attributable cause Bradycardias or apneas, with no other attributable cause Intracranial pressure (ICP) monitoring showing persistent elevation of pressure with or without plateau waves AND No prior history of shunt insertion or endoscopic third ventriculostomy (ETV) procedure (previous temporization devices and/or external ventricular drains permissible) Exclusion Criteria: Hydrocephalus due to intraventricular hemorrhage in a child born before 37 weeks gestational age; OR Anatomy not suitable for ETV+CPC or anteriorly placed ventriculoperitoneal shunt defined as: Moderate to severe prepontine adhesions on steady state free precession (SSFP) or T2 weighted fast (turbo) spin echo (FSE/TSE) MRI, which includes the following sequences: FIESTA, FIESTA-C, TrueFISP, CISS, Balanced FFE (bFFE), CUBE, SPACE, VISTA, IsoFSE, and 3D MVOX Closure of one or both foramina of Monro Thick floor of third ventricle (≥ 3mm) Narrow third ventricle (<5mm) Presence of scalp, bone, or ventricular lesions that make placement of an anterior shunt impracticable; OR Underlying condition with a high chance of mortality within 12 months; OR Hydrocephalus with loculated CSF compartments; OR Peritoneal cavity not suitable for distal shunt placement; OR Active CSF infection; OR Hydranencephaly; OR Child requires an intraventricular procedure (e.g. endoscopic biopsy) in addition to the initial first-time permanent procedure for the treatment of hydrocephalus.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nichol Nunn
Phone
801-662-5344
Email
nichol.nunn@hsc.utah.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Clawson
Phone
801-662-5369
Email
jason.clawson@hsc.utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Kestle, MD
Organizational Affiliation
University of Utah
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Abhaya Kulkarni, MD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Limbrick, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Holubkov, PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anastasia Arynchyna, MPH
Phone
205-638-5018
Email
anastasia.arynchyna@childrensal.org
First Name & Middle Initial & Last Name & Degree
Curtis Rozzelle, MD
Facility Name
Children's Hospital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas Chapman
Email
nchapman@chla.usc.edu
First Name & Middle Initial & Last Name & Degree
Mark Krieger, MD
First Name & Middle Initial & Last Name & Degree
Jason Chu, MD
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Staulcup, 80045
Phone
303-724-5935
Email
SUSAN.STAULCUP@UCDENVER.EDU
First Name & Middle Initial & Last Name & Degree
Todd Hankinson, MD
Facility Name
Wolfson Children's Hospital
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asmaa Hatem
Phone
904-633-0993
Email
Asmaa.Hatem@jax.ufl.edu
First Name & Middle Initial & Last Name & Degree
Philipp R. Aldana, MD
Facility Name
Arnold Palmer Hospital for Children
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tyler W. Teneyck, BS
Phone
321-841-1986
Email
tyler.teneyck@orlandohealth.com
First Name & Middle Initial & Last Name & Degree
Samer Elbabaa, MD
Facility Name
Johns Hopkins Children's Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joan Yea
Email
jyea1@jhu.edu
First Name & Middle Initial & Last Name & Degree
Eric Jackson, MD
Facility Name
St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego Morales, MS
Phone
314-454-4688
Email
moralesd@wudosis.wustl.edu
First Name & Middle Initial & Last Name & Degree
David Limbrick, MD, PhD
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shweta Saraswat, MPH
Email
Shweta.Saraswat@nationwidechildrens.org
First Name & Middle Initial & Last Name & Degree
Jonathan Pindrik, MD
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Diamond, BS, BA
Phone
412-692-9965
Email
diamondkl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Ian Pollack, MD
Facility Name
The Pennsylvania State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Monroe Carell Jr. Children's Hospital at Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Stone
Phone
205-639-7677
Email
timoethia.m.stone@vumc.org
First Name & Middle Initial & Last Name & Degree
John C. Wellons, III, MD, MSPH
First Name & Middle Initial & Last Name & Degree
Robert Naftel, MD
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edgardo Santisbon
Phone
832-826-5208
Email
exsantis@texaschildrens.org
First Name & Middle Initial & Last Name & Degree
William E. Whitehead, MD, MPH
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Clawson
Phone
801-662-5369
Email
jason.clawson@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
John Kestle, MD
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Anderson, BSN, RN
Phone
206-987-5916
Email
amya9@uw.edu
First Name & Middle Initial & Last Name & Degree
Jason Hauptman, MD
First Name & Middle Initial & Last Name & Degree
Samuel Browd, MD, PhD
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruksana Rashid, MBBS MPH MSc
Phone
403-955-5738
Email
rsrashid@ucalgary.ca
First Name & Middle Initial & Last Name & Degree
Jay Riva-Cambrin, MD
Facility Name
British Columbia Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Cheong, BSc
Phone
604-875-2345
Ext
7132
Email
alexander.cheong@cw.bc.ca
First Name & Middle Initial & Last Name & Degree
Mandeep Tamber, MD, PhD
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Homa Ashrafpour
Phone
416-813-7654
Ext
328771
Email
homa.ashrafpour@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Abhaya Kulkarni, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After subject enrollment and 5 year follow up have been completed, we will prepare a final study database for analysis. A releasable database will be produced and completely de-identified in accordance with the definitions provided in the Health insurance Portability and Accountability Act (HIPAA). Namely, all identifiers specified in HIPAA will be recoded in a manner that will make it impossible to deduce or impute the specific identity of any patient. The database will not contain any institutional identifiers. We will also prepare a data dictionary that provides a concise definition of every data element included in the database. If specific data elements have idiosyncrasies that might affect interpretation or analysis, this will be discussed in the dictionary document. In accordance with policies determined by the investigators and funding sponsors, the releasable database will be provided to users in electronic form.
IPD Sharing Time Frame
Within one year of primary publication or within 18 months of the last study visit of the last subject, whichever occurs first.

Learn more about this trial

HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

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