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

Recruiting now

Conditions studied: Perinatal Asphyxia, Hypothermia Treatment, Gestational Age Min. 36SSW

In brief

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.

Key facts

Study ID

NCT06611254

Run by

University of Erlangen-Nürnberg Medical School

People needed

20

Starts

2024-06-24

Expected to finish

2027-12-01

Last updated by the study team

2024-09-24

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• FAU Erlangen-Nuernberg — Erlangen, Bavaria, Germany (enrolling)

Full record on ClinicalTrials.gov

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