RecruitingNCT06611254

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


Sponsor

University of Erlangen-Nürnberg Medical School

Enrollment

20 participants

Start Date

Jun 24, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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

Inclusion Criteria13

  • 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 Criteria3

  • Lack of consent of at least one parent
  • Pre-existing brain malformations
  • Absence of the competent examiner

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Interventions

DEVICEContrast enhanced ultrasound imaging (CEUS) and post processing with ULM

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.


Locations(1)

FAU Erlangen-Nuernberg

Erlangen, Bavaria, Germany

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NCT06611254


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