Quantification of Brain and Kidney Perfusion Before, During, and After Hypothermia Treatment in Neonates With Perinatal Asphyxia Using Contrast-enhanced Ultrasound

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of Erlangen-Nürnberg Medical School

About this trial

In this clinical study vascular dynamics in the neonatal brain and kidney will be monitored by CUES and ULM before, during and after hypothermia treatment in neonates with asphyxia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fulfillment of the inclusion criteria for hypothermia treatment according to the AWMF guideline

Severe acidosis (pH ≤7.0 or a base deficit ≥16 mmol/l) in umbilical cord blood or a blood sample from the first hour of life, and

clinical signs of moderate or severe encephalopathy (severity grade 2 or 3 according to Sarnat & Sarnat), and

postnatal age ≤6h, and

Disqualifiers

Lack of consent of at least one parent

Pre-existing brain malformations

Absence of the competent examiner

Trial population

One study population. Anticipated approx. n=20 neonateswith above mentioned inclusion criteria with perinatal asphyxia and inclusion criteria for hypothermia treatmentaccording to the AWMF guideline.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Contrast enhanced ultrasound imaging (CEUS) and post processing with ULM

    Device

    CEUS is a contrast based ultrasound technique and ULM (Ultrasound Localization Microscopy) is a post-processing bioinformatical method to quantify microvascular architecture and perfusion dynamics.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Neonates with perinatal asphyxia and indication for hypothermia treatment1 intervention

Trial outcomes

Primary outcomes

1

CEUS Time intensity curves

All CEUS outcomes will be generated in order to achieve time intensity curves in contrast enhanced ultrasound analysis

Time frame
before(T1, within the first 6hours of life), during hypothermia treatment(T2, 6-78hours of life), after treatment (T3, within first week of life)
2

CEUS Measurement1

PE (Peak-Enhancement)

Time frame
before(T1, within the first 6hours of life), during hypothermia treatment(T2, 6-78hours of life), after treatment (T3, within first week of life)
3

CEUS Measurement2

WiAUC (Wash-in Area Under the Curve (AUC(TI: TTP)))

Time frame
before(T1, within the first 6hours of life), during hypothermia treatment(T2, 6-78hours of life), after treatment (T3, within first week of life)
4

CEUS Measurement3

WiAUC (Wash-in Area Under the Curve (AUC(TI: TTP)))

Time frame
before(T1, within the first 6hours of life), during hypothermia treatment(T2, 6-78hours of life), after treatment (T3, within first week of life)

Secondary outcomes

1

CEUS and NIRS

Correlation coefficient (R) between CEUS curve and NIRS

Time frame
T1,T2,T3
2

Neurological status assessment (Bayley Score)

Neurological status of the patients will be assessed by the score "Bayley Scales of Infant and Toddler Development"

Time frame
Month of life: 3-4 and 6-24
3

MRI imaging in asphyxia

MRI Weeke Score

Time frame
once within first two years of life
4

Comparison of the CEUS time-intensity curve between three timepoints

CEUS curve at T1,T2, T3

Time frame
T1,T2, T3

Other outcomes

Sponsors and contacts

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