Post-Hemorrhagic HydrocephalusSOPHHNCT01480349
Shunt Outcomes of Post-Hemorrhagic Hydrocephalus
An observational study of Post-Hemorrhagic Hydrocephalus, run by University of Utah at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 180 days
- Conditions the study is for
- Post-Hemorrhagic Hydrocephalus
- How many people
- 146 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 10 Jan 2011to 10 May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 180 days
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- Less than 72 hour life expectancy from other medical problems
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Children's Hospital of Alabama
Birmingham, Alabama, 35233
Texas Children's Hospital
Houston, Texas, 77030
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Primary Children's Hospital
Salt Lake City, Utah, 84113
Seattle Children's Hospital
Seattle, Washington, 98105
St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
Official title: Shunt Outcomes of Post-Hemorrhagic Hydrocephalus: A Network Pilot Study
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.
Read the 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.
- Conditions
- Post-Hemorrhagic Hydrocephalus
- Keywords
- Post-Hemorrhagic Hydrocephalus, Intraventricular Hemorrhage, Low Birth Weight Premature Infants
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific Aim I: Proportion of temporization
The proportion of all infants entering the study who meet the criteria for surgical temporization.
Measured: 5 years
Specific Aim 2: Conversion proportion
The proportion of all infants with SGS or RES who met criteria for conversion to permanent shunt.
Measured: 5 years
Specific Aim 3: Surgery Checklist Scores
Surgery checklist scores of individual surgeon performance in standardized procedures.
Measured: 5 years
Secondary outcomes (3)
Protocol adherence
Protocol adherence by network, center, surgeon, decision rubric, and individual decision data points.
Measured: 5 years
CSF Infection
Incidence of CSF infection while on the protocol.
Measured: 5 years
Neurodevelopmental Outcomes
Subscores from the Bayley Scales of Infant Development, version III (BSID-III) to include cognitive, language and motor subtests will be obtained for patients undergoing BSID-III testing at 18-22 and 36-42 months of age.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2011 (estimated)
- Study start10 Jan 2011
- Primary completion10 May 2016
- Study completion10 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Hemorrhagic HydrocephalusStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John C Wellons, III, MD, Study chair, Vanderbilt University Medical CenterChevis N Shannon, MBA, DrPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480349
- Sponsor's protocol ID
- 46249
- Other IDs
- 1RC1NS068943-01, HCRN 005
- Acronym
- SOPHH
- Status last verified
- Dec 2017
- First submitted
- 23 Nov 2011
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shunt Outcomes of Post-Hemorrhagic Hydrocephalus: A Network Pilot Study
- ClinicalTrials.gov ID
- NCT01480349
- Acronym / sponsor ID
- SOPHH / 46249
- Conditions
- Post-Hemorrhagic Hydrocephalus
- Keywords
- Post-Hemorrhagic Hydrocephalus, Intraventricular Hemorrhage, Low Birth Weight Premature Infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 10 Jan 2011 (actual)
- Primary completion
- 10 May 2016 (actual)
- Study completion
- 10 May 2016 (actual)
- First posted
- 28 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 180 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Less than 72 hour life expectancy from other medical problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Specific Aim I: Proportion of temporization
Time frame: 5 years
The proportion of all infants entering the study who meet the criteria for surgical temporization.
Specific Aim 2: Conversion proportion
Time frame: 5 years
The proportion of all infants with SGS or RES who met criteria for conversion to permanent shunt.
Specific Aim 3: Surgery Checklist Scores
Time frame: 5 years
Surgery checklist scores of individual surgeon performance in standardized procedures.
3 secondary outcomes
Protocol adherence
Time frame: 5 years
CSF Infection
Time frame: 5 years
Neurodevelopmental Outcomes
Time frame: 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- Hydrocephalus Clinical Research Network websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John C Wellons, III, MD study chair
Vanderbilt University Medical Center
Chevis N Shannon, MBA, DrPH principal investigator
Vanderbilt University Medical Center
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Hemorrhagic Hydrocephalus, run by University of Utah at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specific Aim I: Proportion of temporization (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2017.