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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Contrast enhanced ultrasound imaging (CEUS) and post processing with ULM
DeviceCEUS 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
Trial outcomes
Primary outcomes
CEUS Time intensity curves
All CEUS outcomes will be generated in order to achieve time intensity curves in contrast enhanced ultrasound analysis
CEUS Measurement1
PE (Peak-Enhancement)
CEUS Measurement2
WiAUC (Wash-in Area Under the Curve (AUC(TI: TTP)))
CEUS Measurement3
WiAUC (Wash-in Area Under the Curve (AUC(TI: TTP)))
Secondary outcomes
CEUS and NIRS
Correlation coefficient (R) between CEUS curve and NIRS
Neurological status assessment (Bayley Score)
Neurological status of the patients will be assessed by the score "Bayley Scales of Infant and Toddler Development"
MRI imaging in asphyxia
MRI Weeke Score
Comparison of the CEUS time-intensity curve between three timepoints
CEUS curve at T1,T2, T3
Sponsors and contacts
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