HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

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Brief Title

HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

Official Title

Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Bayley Scale of Infant Development-IV (Bayley-IV) Cognitive Scale score

Secondary Outcome

 Bayley Scale of Infant Development-IV (Bayley-IV) Language Scaled Score

Condition

Hydrocephalus

Intervention

Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC)

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

176

Start Date

July 21, 2020

Completion Date

September 30, 2026

Primary Completion Date

January 30, 2024

Eligibility Criteria

        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.
      

Gender

All

Ages

0 Days - 104 Weeks

Accepts Healthy Volunteers

No

Contacts

John Kestle, MD, 801-662-5344, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT04177914

Organization ID

HCRN 012

Secondary IDs

1U01NS107486-01A1

Responsible Party

Principal Investigator

Study Sponsor

University of Utah

Collaborators

 University of Alabama at Birmingham

Study Sponsor

John Kestle, MD, Study Chair, University of Utah


Verification Date

July 2022