NCT03061045

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2017

Shorter than P25 for phase_4

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2018

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

10 months

First QC Date

February 9, 2017

Last Update Submit

January 22, 2018

Conditions

Neonatal Post-Hemorrhagic Hydrocephalus

Outcome Measures

Primary Outcomes (6)

  • 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.

    Immediately before and after ventricular shunting

  • 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.

    Immediately before and after ventricular shunting

  • 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.

    Immediately before and after ventricular shunting

  • 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.

    Immediately before and after ventricular shunting

  • 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.

    Immediately before and after ventricular shunting

  • 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.

    Immediately before and after ventricular shunting

Study Arms (1)

Contrast Enhanced Brain Ultrasound

EXPERIMENTAL

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]

Interventions

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

All patients enrolled in this study will undergo contrast enhanced ultrasound examination for assessment of brain perfusion.

Contrast Enhanced Brain Ultrasound

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preexisting IV line
  • Stable clinical condition
  • No prior allergy to ultrasound contrast agents
  • Presence of post-hemorrhagic hydrocephalus

You may not qualify if:

  • Unstable clinical condition
  • Inability to complete the exam
  • Allergy to ultrasound contrast agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Suspensions

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • Misun Hwang, M.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2017

First Posted

February 23, 2017

Study Start

April 1, 2017

Primary Completion

January 22, 2018

Study Completion

January 22, 2018

Last Updated

January 25, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share