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

Recruitingn/aAges any - anyAllUniversity of Erlangen-Nürnberg Medical School
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * gestational age ≥36 weeks' gestation * Consent of the parents/legal guardians * Time 1 (before the start of hypothermia treatment) * Informing the parents/legal guardians present on site despite an emotionally stressful situation with high individual benefit for the patient * If only one parent is present and able to provide information, their consent is sufficient - the second parent is informed repeatedly when they regain the ability to provide information * Information adapted to the emergency situation, addressing the personal situation and comprehensible presentation of the plan * Time 2 (during hypothermia treatment) --\>Offer of a further informative discussion/repeated explanation with the parents/legal representatives before the second measurement in order to answer any questions that may have arisen * Suitable acoustic window * Availability of the qualified examiner Exclusion Criteria: * Lack of consent of at least one parent * Pre-existing brain malformations * Absence of the competent examiner
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What it tests

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

1 site
FAU Erlangen-Nuernberg
Erlangen, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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