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Trial record 11 of 44 for:    CSF | "Hydrocephalus"

Micro Ribonucleic Acid (miRNA) Markers of Hydrocephalus in Intraventricular Hemorrhage (IVH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02386228
Recruitment Status : Terminated
First Posted : March 11, 2015
Last Update Posted : January 6, 2017
Translational Genomics Research Institute
Information provided by (Responsible Party):
Madelon Petersen, St. Joseph's Hospital and Medical Center, Phoenix

Brief Summary:
A collection of biological samples (cerebrospinal fluid [CSF] and blood) from patients under 6 years of age who are diagnosed with intraventricular hemorrhage or spina bifida.

Condition or disease Intervention/treatment
Intraventricular Hemorrhage Spina Bifida Genetic: collection of CSF and blood

Detailed Description:
IVH is an important cause of brain injury in newborns and more so in those born prematurely. Depending on the severity of the hemorrhage and the care provided the newborn, the impact of IVH can range from a temporary issue with no permanent consequences to a life-threatening condition with severe neurodevelopmental sequelae. The outcomes of patients with IVH are not only dictated by the direct effects of the hemorrhage, but to associated processes such as hydrocephalus, periventricular infarction and leukomalacia. Despite the availability of better diagnostic and therapeutic tools, the incidence of IVH has remained constant over the past 50 years, and is mostly due to the increased survival rates of very low weight premature infants. Recent statistics demonstrate that close to 12,000 premature infants develop IVH in the United 'states every year and more than 50% of them develop some degree of posthemorrhagic hydrocephalus (PHH). It is believed that PHH originates as a result or arachnoiditis, gliosis, and subsequent fibrosis impairing the flow and reabsorption of cerebrospinal fluid (CSF). Despite the lack of clarity about the pathogenesis of PHH, it is well accepted that its presence exacerbates the damage caused by the hemorrhage to the periventricular white matter. Multiple efforts have been made to identify the mechanisms and mediators of the development of PHH and white matter damage. Molecules such as transforming growth factor-beta (TGF-beta) have been demonstrated to enhance the expression of genes encoding for fibronectin, collagen and other extracellular matrix components. Unfortunately, not enough evidence has been generated to be able to envision a potential solution for the problem. The current management of PHH is focused on controlling the damage that pressure, distortion, and/or ischemia may cause to the immature brain. Direct evacuation of ventricular contents with CSF diversion mechanisms remains, such as sequential lumber punctures, external ventricular draining, and reservoir placement. Intraventricular fibrinolytic therapy or permanent shunting represent most effective tools by mechanically evacuating bleeding products and preventing the accumulation of CSF. However, they are all highly invasive techniques that carry major risks and complications. The use of diuretics has been presented as a non-invasive alternative, but the results prove them inefficient. Extracellular miRNA sequences have been found to be major modulators of protein coding genes involved in differentiation, proliferation, and apoptosis. Several studies have reported the presence of significant amounts of miRNA in extracellular fluids such as plasma, urine, saliva, and semen. The researchers believe that extracellular miRNAs are present in CSF and that sequential evaluation of their expression can provide a unique biomarker signature, time sensitive enough to reflect the evolution of pathological events underlying the development of PHH. The identification of a miRNA biomarker for PHH development and/or hemorrhagic related injury would also be a means to quickly evaluate treatment response.

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Study Type : Observational
Actual Enrollment : 1 participants
Time Perspective: Prospective
Official Title: miRNA Markers of Hydrocephalus in Intraventricular Hemorrhage (IVH)
Study Start Date : March 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Intervention Details:
  • Genetic: collection of CSF and blood
    collection of CSF and blood

Primary Outcome Measures :
  1. miRNA sequences [ Time Frame: within 30 days of blood or CSF collection ]
    Identification of miRNA sequences common to patients with IVH and patients with spina bifida to determine condition specific expression profiles, multivariate analysis of candidate miRNA sequences that are differentially expressed between the two conditions but between different outcomes (development of hydrocephalus) to target potential markers. Once identified, mechanisms for the rapid detection of marker sequences will be developed and their predictive value tested in future collections.

Biospecimen Retention:   Samples With DNA
CSF and blood

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
infants with IVH or spina bifida

Inclusion Criteria:

  • Age between 0 and 6 years.
  • Diagnosis of IVH or spina bifida
  • Granted access to CSF and blood via surgery, CSF diversion device, venous access, and/or arterial access.

Exclusion Criteria:

  • Older than 6 years.
  • Diagnosis of infection or other acute inflammatory process involving the central nervous system.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02386228

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United States, Arizona
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Sponsors and Collaborators
St. Joseph's Hospital and Medical Center, Phoenix
Translational Genomics Research Institute
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Principal Investigator: Robert Spetzler, MD Barrow Brain and Spine physician with SJHMC privileges

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Responsible Party: Madelon Petersen, Research Clinician, St. Joseph's Hospital and Medical Center, Phoenix Identifier: NCT02386228     History of Changes
Other Study ID Numbers: 14BN104
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: January 6, 2017
Last Verified: January 2017

Keywords provided by Madelon Petersen, St. Joseph's Hospital and Medical Center, Phoenix:
posthemorrhagic hydrocephalus (PHH)

Additional relevant MeSH terms:
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Cerebral Hemorrhage
Spinal Dysraphism
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Neural Tube Defects
Nervous System Malformations
Congenital Abnormalities