Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The International Study Group for Neuroendoscopy (ISGNE) | UNKNOWN |
| The International Society for Pediatric Neurosurgery | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ETV | Active Comparator |
| |
| CSF Shunt | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Health Status Outcome as measured by the Health Utilities Index - 2 | At 5 years of age |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Medical Center of Dallas | Dallas | Texas | 75235 | United States | ||
| Nacional de Pediatria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29987375 | Derived | 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. | |
| 28357554 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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 |
| Surgical Morbidity | Duration of the Study |
| Incidence of failure of initial intervention | Duration of the Study |
| Hospitalization Time | 5 years post-operation |
| Need for repeat radiological scans | Duration of the Study |
| Complications such as CNS infection, focal neurological deficit, significant hemorrhage, seizures requiring medication | Duration of the Study |
| Ventricular size and the existence of flow void (ETV group)assessed through radiological evaluation | 3 years of age |
| Buenos Aires |
| Argentina |
| Biocor Instituto | Nova Lima | Brazil |
| UNIFESP | São Paulo | Brazil |
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| University Hospital Gießen and Marburg | Giessen | Germany |
| University of Debrecen | Debrecen | Hungary |
| Sanjay Gandhi Postgraduate Institute of Medical Sciences | Lucknow | India |
| All India Institute of Medical Sciences | New Delhi | India |
| Dana Children's Hospital, Tel Aviv Medical Center | Tel Aviv | Israel |
| Giannina Gaslini Hospital | Genova | Italy |
| Catholic University Medical School Rome | Rome | Italy |
| University Medical Center St Radboud | Nijmegen | Netherlands |
| Medical University of Silesia | Katowice | Poland |
| Polish Mother's Memorial Hospital | Lodz | Poland |
| Children's Memorial Health Institute | Warsaw | Poland |
| Burdenko Neurosurgical Institute | Moscow | Russia |
| Institute for Neurosurgery | Belgrade | Serbia |
| Hospital Sant Joan de Deu | Barcelona | Spain |
| Hacettepe University Hospital | Ankara | Turkey (Türkiye) |
| Birmingham Children's Hospital | Birmingham | United Kingdom |
| Alder Hey Children's Hospital | Liverpool | United Kingdom |
| 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. |
| 27107887 | 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. |
| ID | Term |
|---|---|
| D006849 | Hydrocephalus |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014696 | Ventriculostomy |
| ID | Term |
|---|---|
| D002557 | Cerebrospinal Fluid Shunts |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D019635 | Neurosurgical Procedures |
Not provided
Not provided