Clinical trial NCT01480349: Shunt Outcomes of Post-Hemorrhagic Hydrocephalus
Official title: Shunt Outcomes of Post-Hemorrhagic Hydrocephalus: A Network Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-Hemorrhagic Hydrocephalus
Keywords: Post-Hemorrhagic Hydrocephalus
Intraventricular Hemorrhage
Low Birth Weight Premature Infants
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2011-11-28
Enrollment: 146
Sex: ALL
Maximum age (years): 180
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All premature neonates with grade III or IV intraventricular hemorrhage who primarily present or are referred prior to surgical intervention for post hemorrhagic hydrocephalus to HCRN Clinical Centers.

Brief summary: This multicenter, prospective pilot study will compare the effectiveness of two established procedures used in the treatment of post-hemorrhagic hydrocephalus in very low birth weight infants, specifically ventricular reservoirs and subgaleal shunts. The study is being conducted by the Hydrocephalus Clinical Research Network (HCRN), a network established to conduct multi-institutional clinical trials on pediatric hydrocephalus.

Detailed description: Intraventricular hemorrhage and post-hemorrhagic hydrocephalus remain a leading cause of mortality and long-term morbidity in premature infants. The two most common temporary cerebrospinal fluid (CSF) diversion procedures are the ventriculosubgaleal shunt (SGS) and an implanted ventricular reservoir (RES) for intermittent CSF removal. These methods are physiologically very different and their comparative effectiveness in treating hydrocephalus and possibly reducing the need for an eventual permanent CSF shunt is currently not known. The goal of this pilot study is to obtain information critical for planning and executing a future randomized trial comparing SGS and RES. Specifically, this pilot study will establish inclusion criteria, define the primary outcome, and standardize the interventions in preparation for initiating a comparative trial between the SGS and RES procedures. In addition, the importance of examining the neurodevelopmental outcomes for these patients has been recognized within the neurosurgical and neuropsychological settings. Therefore, the scope of this study has been extended to include an examination of the neurodevelopmental outcomes at 18 to 22 months and at 36 to 42 months in patients who undergo BSID-III testing at their clinical centers.

Eligibility criteria: Inclusion Criteria:

* premature neonates with birth weights less than 1500 grams
* Grade III or IV intraventricular hemorrhage
* Fronto-occipital horn ratio greater than or equal to 0.50

Exclusion Criteria:

* Less than 72 hour life expectancy from other medical problems

Primary outcomes:
measure: Specific Aim I: Proportion of temporization
timeFrame: 5 years
measure: Specific Aim 2: Conversion proportion
timeFrame: 5 years
measure: Specific Aim 3: Surgery Checklist Scores
timeFrame: 5 years
Secondary outcomes:
measure: Protocol adherence
timeFrame: 5 years
measure: CSF Infection
timeFrame: 5 years
measure: Neurodevelopmental Outcomes
timeFrame: 7 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's Hospital of Alabama
state: Alabama
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Toronto
country: Canada
facility: Sick Children's Hospital
state: Ontario
Study officials:
affiliation: Vanderbilt University Medical Center
name: John C Wellons, III, MD
role: STUDY_CHAIR
affiliation: Vanderbilt University Medical Center
name: Chevis N Shannon, MBA, DrPH
role: PRINCIPAL_INVESTIGATOR
References: