- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03061045
Contrast Enhanced Ultrasound Evaluation of Brain Perfusion in Neonatal Post-Hemorrhagic Hydrocephalus
January 22, 2018 updated by: Johns Hopkins University
The aim of the proposed project is therefore to utilize the CEUS technique to assess cerebral perfusion changes before and after ventricular shunting in neonatal cases of PHH.
The expectation of the proposed project is to validate statistically significant cerebral perfusion differences before and after shunting in neonates with PHH, as a preliminary feasibility study prior to conducting a large scale, prospective clinical trial incorporating therapeutic interventions using the CEUS technique.
Study Overview
Status
Withdrawn
Conditions
Detailed Description
Timely decompression of post-hemorrhagic hydrocephalus (PHH) due to intraventricular hemorrhage in premature babies is key to reducing long-term cognitive and motor disability.
Exactly when to place a ventricular shunt for decompression and alleviation of increased intracranial pressure (ICP) remains a dilemma for neurosurgeons, and the only guidance is based on changes in size of the ventricles not necessarily reflective of cerebral hemodynamics.
There is a dire need for a novel diagnostic tool that can perform serial, bedside assessment of cerebral perfusion.
At times, intermittent shunting may be needed depending on the dynamic changes in brain perfusion, and this is not practical with the current diagnostic tools.
While most diagnostic techniques require sedation or transport (i.e.
magnetic resonance imaging), few available bedside techniques (i.e.
near infrared spectroscopy or Doppler ultrasound) are limited soft tissue contrast, depth of penetration, and/or ability to quantify cerebral perfusion.
Potential long-term effects of sedation in neonates are also relatively unknown.
In this regard, contrast enhanced ultrasound (CEUS) is easily repeatable technique that can be performed at bedside in less than 5 minutes and provide dynamic cerebral perfusion quantification.
The aim of the proposed project is therefore to utilize the CEUS technique to detect cerebral perfusion changes before and after ventricular shunting in neonatal cases of PHH.
The specific hypothesis behind the proposed research is that impaired cerebral perfusion in PHH correlates with long-term cognitive and motor disability.
The hypothesis is based on the following evidence.
First, substantial data from animal studies of hydrocephalus demonstrate a significant role of impaired cerebral hemodynamics in the pathophysiology of brain injury in PHH.
Second, animal studies have clearly shown that early treatment of hydrocephalus reduces brain injury and cognitive development.
Third, preliminary studies of human infants validate aforementioned findings from animal studies.
The expectation of the proposed project is to validate statistically significant cerebral perfusion differences before and after shunting in neonates with PHH, as a preliminary feasibility study prior to conducting a large scale, prospective clinical trial incorporating therapeutic interventions.
Study Type
Interventional
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Preexisting IV line
- Stable clinical condition
- No prior allergy to ultrasound contrast agents
- Presence of post-hemorrhagic hydrocephalus
Exclusion Criteria:
- Unstable clinical condition
- Inability to complete the exam
- Allergy to ultrasound contrast agents
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Contrast Enhanced Brain Ultrasound
Neonates with post-hemorrhagic hydrocephalus recruited for this study will all undergo contrast enhanced ultrasound examination of the head, a diagnostic intervention for the study.
|
All patients enrolled in this study will undergo contrast enhanced ultrasound examination for assessment of brain perfusion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wash-In Slope (Intensity in dB/Sec)
Time Frame: Immediately before and after ventricular shunting
|
Wash-In Slope as derived from contrast enhanced ultrasound perfusion kinetics curve will be obtained as one quantifiable measure of brain perfusion in neonates with post-hemorrhagic hydrocephalus.
|
Immediately before and after ventricular shunting
|
Peak Intensity (Intensity in dB)
Time Frame: Immediately before and after ventricular shunting
|
Peak Intensity as derived from contrast enhanced ultrasound perfusion kinetics curve will be obtained as one quantifiable measure of brain perfusion in neonates with post-hemorrhagic hydrocephalus.
|
Immediately before and after ventricular shunting
|
Time to Peak (sec)
Time Frame: Immediately before and after ventricular shunting
|
Time to Peak as derived from contrast enhanced ultrasound perfusion kinetics curve will be obtained as one quantifiable measure of brain perfusion in neonates with post-hemorrhagic hydrocephalus.
|
Immediately before and after ventricular shunting
|
Area Under the Curve (Intensity in dB x sec)
Time Frame: Immediately before and after ventricular shunting
|
Area Under the Curve as derived from contrast enhanced ultrasound perfusion kinetics curve will be obtained as one quantifiable measure of brain perfusion in neonates with post-hemorrhagic hydrocephalus.
|
Immediately before and after ventricular shunting
|
Mean Transit Time (sec)
Time Frame: Immediately before and after ventricular shunting
|
Mean Transit Time as derived from contrast enhanced ultrasound perfusion kinetics curve will be obtained as one quantifiable measure of brain perfusion in neonates with post-hemorrhagic hydrocephalus.
|
Immediately before and after ventricular shunting
|
Time to Peak to 1/2 (sec)
Time Frame: Immediately before and after ventricular shunting
|
Time to peak to 1/2 as derived from contrast enhanced ultrasound perfusion kinetics curve will be obtained as one quantifiable measure of brain perfusion in neonates with post-hemorrhagic hydrocephalus.
|
Immediately before and after ventricular shunting
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Misun Hwang, M.D., Johns Hopkins University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2017
Primary Completion (Actual)
January 22, 2018
Study Completion (Actual)
January 22, 2018
Study Registration Dates
First Submitted
February 9, 2017
First Submitted That Met QC Criteria
February 17, 2017
First Posted (Actual)
February 23, 2017
Study Record Updates
Last Update Posted (Actual)
January 25, 2018
Last Update Submitted That Met QC Criteria
January 22, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00129090
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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