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Contrast Enhanced Ultrasound Evaluation of Brain Perfusion in Neonatal Post-Hemorrhagic Hydrocephalus

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ClinicalTrials.gov Identifier: NCT03061045
Recruitment Status : Withdrawn (PI is leaving the institution)
First Posted : February 23, 2017
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Neonatal Post-Hemorrhagic Hydrocephalus Drug: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON] Phase 4

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  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Contrast Enhanced Ultrasound Evaluation of Brain Perfusion in Neonatal Post-Hemorrhagic Hydrocephalus
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : January 22, 2018
Actual Study Completion Date : January 22, 2018

Resource links provided by the National Library of Medicine


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.
Drug: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON]
All patients enrolled in this study will undergo contrast enhanced ultrasound examination for assessment of brain perfusion.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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 ClinicalTrials.gov identifier (NCT number): NCT03061045


Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Misun Hwang, M.D. Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03061045     History of Changes
Other Study ID Numbers: IRB00129090
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases