Contrast Enhanced Ultrasound Evaluation of Brain Perfusion in Neonatal Post-Hemorrhagic Hydrocephalus
Primary Purpose
Neonatal Post-Hemorrhagic Hydrocephalus
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON]
Sponsored by
About this trial
This is an interventional diagnostic trial for Neonatal Post-Hemorrhagic Hydrocephalus
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Contrast Enhanced Brain Ultrasound
Arm Description
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.
Outcomes
Primary Outcome Measures
Wash-In Slope (Intensity in dB/Sec)
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.
Peak Intensity (Intensity in dB)
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.
Time to Peak (sec)
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.
Area Under the Curve (Intensity in dB x sec)
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.
Mean Transit Time (sec)
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.
Time to Peak to 1/2 (sec)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03061045
First Posted
February 9, 2017
Last Updated
January 22, 2018
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT03061045
Brief Title
Contrast Enhanced Ultrasound Evaluation of Brain Perfusion in Neonatal Post-Hemorrhagic Hydrocephalus
Official Title
Contrast Enhanced Ultrasound Evaluation of Brain Perfusion in Neonatal Post-Hemorrhagic Hydrocephalus
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Withdrawn
Why Stopped
PI is leaving the institution
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
January 22, 2018 (Actual)
Study Completion Date
January 22, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Post-Hemorrhagic Hydrocephalus
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Contrast Enhanced Brain Ultrasound
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON]
Intervention Description
All patients enrolled in this study will undergo contrast enhanced ultrasound examination for assessment of brain perfusion.
Primary Outcome Measure Information:
Title
Wash-In Slope (Intensity in dB/Sec)
Description
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.
Time Frame
Immediately before and after ventricular shunting
Title
Peak Intensity (Intensity in dB)
Description
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.
Time Frame
Immediately before and after ventricular shunting
Title
Time to Peak (sec)
Description
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.
Time Frame
Immediately before and after ventricular shunting
Title
Area Under the Curve (Intensity in dB x sec)
Description
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.
Time Frame
Immediately before and after ventricular shunting
Title
Mean Transit Time (sec)
Description
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.
Time Frame
Immediately before and after ventricular shunting
Title
Time to Peak to 1/2 (sec)
Description
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.
Time Frame
Immediately before and after ventricular shunting
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Misun Hwang, M.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Contrast Enhanced Ultrasound Evaluation of Brain Perfusion in Neonatal Post-Hemorrhagic Hydrocephalus
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