Status:
RECRUITING
Quantification of Brain and Kidney Perfusion Before, During, and After Hypothermia Treatment in Neonates With Perinatal Asphyxia Using Contrast-enhanced Ultrasound
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Conditions:
Perinatal Asphyxia
Hypothermia Treatment
Eligibility:
All Genders
Brief 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.
Detailed Description
Perinatal asphyxia (PA) is the reduced supply of oxygen to vital organs during or immediately after birth. PA is one of the most common causes of neonatal mortality in full-term infants worldwide and ...
Eligibility Criteria
Inclusion
- 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
- Lack of consent of at least one parent
- Pre-existing brain malformations
- Absence of the competent examiner
Key Trial Info
Start Date :
June 24 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06611254
Start Date
June 24 2024
End Date
December 1 2027
Last Update
September 24 2024
Active Locations (1)
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1
FAU Erlangen-Nuernberg
Erlangen, Bavaria, Germany, 91054