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Intraventricular HemorrhageNCT02386228

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

An observational study of Intraventricular Hemorrhage and Spina Bifida, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 6 years
Conditions the study is for
Intraventricular Hemorrhage, Spina Bifida
What is being tested?
collection of CSF and blood
How many people
1 participants
Where
1 siteUnited States
Study dates
Mar 2015to Dec 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 6 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: infants with IVH or spina bifida

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

Other trials in United States

About this study

Official title: miRNA Markers of Hydrocephalus in Intraventricular Hemorrhage (IVH)

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.

Read the 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.

Being tested
collection of CSF and blood
Keywords
miRNA, posthemorrhagic hydrocephalus (PHH)
Medical subject headings
Spinal Dysraphism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • collection of CSF and bloodGenetic

    collection of CSF and blood

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. miRNA sequences

    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.

    Measured: within 30 days of blood or CSF collection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02386228
Sponsor's protocol ID
14BN104
Status last verified
Jan 2017
First submitted
5 Mar 2015
Last updated
6 Jan 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Intraventricular Hemorrhage and Spina Bifida, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.

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 2 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: stopped early, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 was stopped early. Results are not available in the source record.

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?

miRNA sequences (time frame: within 30 days of blood or CSF collection). 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 6 Jan 2017.

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