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
Interested in this trial?
Get notified about updates and connect with the research team.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06611254