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Clinical Trials/NCT03061045
NCT03061045
Withdrawn
Phase 4

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

Johns Hopkins University0 sitesApril 1, 2017

Overview

Phase
Phase 4
Intervention
Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON]
Conditions
Neonatal Post-Hemorrhagic Hydrocephalus
Sponsor
Johns Hopkins University
Primary Endpoint
Wash-In Slope (Intensity in dB/Sec)
Status
Withdrawn
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2017
End Date
January 22, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

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.

Intervention: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON]

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

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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