Quantification of Cerebral Perfusion by Contrast-enhanced Ultrasound During Neonatal Heart Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-04

Study Completion Date

2021-08-30

Brief Summary

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Transcranial contrast-enhanced ultrasound for evaluation of cerebral blood flow during pediatric cardiac surgery. This study is aimed as a feasibility study prior to conducting a lager prospective clinical trial including neurologic and developmental outcome measures.

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Detailed Description

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The cerebral perfusion of infants with congenital heart defects is a critical determinant during cardiac surgery. The majority of these interventions is performed during deep or moderate hypothermia (25-32°C) with reduced blood flow of the heart-lung-machine (HLM). Assuming a symmetrical anatomy of the cerebral arteries (C. Willisii) a single vessel (T. brachiocephalicus) is then supplying the cerebral blood flow. Using contrast-enhanced ultrasound the cerebral blood flow will be assessed during cardiac surgery interventions.

Conditions

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Heart Defects, Congenital

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Group A - TCEUS with HLM

General neonatal cardiac surgery with HLM (art. switch, aortopulmonary shunts)

Group Type ACTIVE_COMPARATOR

TCEUS

Intervention Type DIAGNOSTIC_TEST

Intravenous sulphur hexafluoride microbubbles

Group B - TCEUS with HLM

Surgery of the aortic arc

Group Type EXPERIMENTAL

TCEUS

Intervention Type DIAGNOSTIC_TEST

Intravenous sulphur hexafluoride microbubbles

Group C - TCEUS without HLM

Neonatal cardiac surgery without HLM

Group Type ACTIVE_COMPARATOR

TCEUS

Intervention Type DIAGNOSTIC_TEST

Intravenous sulphur hexafluoride microbubbles

Interventions

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TCEUS

Intravenous sulphur hexafluoride microbubbles

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Transcranial contrast-enhanced ultrasound

Eligibility Criteria

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Inclusion Criteria

* Neonates and infants ≤ 4 month (open fontanelle)
* Proper ultrasound conditions/window
* Appropriate general and neurologic state of health
* Written consent of both parents/guardians
* Availability of trained sonographer (medical doctor)

Exclusion Criteria

* Absence of trained sonographer (medical doctor)
* Intolerance against SonoVue® (bzw. sulphur hexafluoride)
* Missing signed consent
* Reduced or inappropriate general and neurologic state of health
* Preexisting cerebral injury

Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No