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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2027
  • participants needed
    20
  • sponsor
    University of Erlangen-Nürnberg Medical School
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Updated on 26 September 2024
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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. HELLO TEST 123

Participants will be asked to provide biological samples at different time points during your pregnancy and delivery of your baby.  
 

 

These samples may be collected when you are getting other clinical tests done or you may be asked to have your blood drawn utilizing a drive up location or research visit.  
 

 

Your health information will also be collected.

 

Participants will be asked to provide biological samples at different time points during your pregnancy and delivery of your baby.  
 

 

These samples may be collected when you are getting other clinical tests done or you may be asked to have your blood drawn utilizing a drive up location or research visit.  
 

 

Your health information will also be collected.

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 of hypoxic-ischemic encephalopathy (HIE) with subsequent neurological deficits (spastic cerebral palsy). In addition to brain damage, perinatal asphyxia often leads to dysfunction of other organs. It is not uncommon for this to be accompanied by transient renal failure.

Hypothermia treatment is an established therapeutic measure for neuroprotection in clinical indications of HIE. This involves lowering the core body temperature of affected children to 33.5°C for 72 hours. The therapeutic effect is thought to be due to multifactorial mechanisms, including a reduction in endothelial dysfunction, reduced excretion of free radicals and attenuation of the inflammatory cascade.

In the guidelines for hypothermia treatment in neonatal asphyxia, regular ultrasound examinations are prescribed to clarify damage to the central nervous system (CNS) before, during and after hypothermia treatment.1 In infants, transfontal ultrasound makes it possible to visualize brain structures, vessels and their flow velocities.

The intravenous use of ultrasound contrast enhancers as an aid also opens up the possibility of recording the tissue perfusion of the CNS and kidneys, including the smallest vessels.8 This could provide significantly more information compared to conventional methods and expand our knowledge of the pathophysiology and individual status of tissue perfusion in patients.

For example, two studies at Erlangen University Hospital have successfully used contrast-enhanced ultrasound (CEUS) with the contrast agent known as SonoVue® to visualize postoperative perfusion of the brain after pediatric cardiac surgery.

In this clinical study, the new CEUS measurement and imaging technique will be used before, during and after hypothermia treatment in neonates with asphyxia. A contrast agent (SonoVue®) will be administered during the routine ultrasound examination and improved tissue visualization will be achieved. The aim is to gain new insights into brain and kidney perfusion as part of the treatment and to better assess the extent of organ damage in the individual patient through more specific vascular imaging. Improved visualization and assessment of the end-stream area will provide information on processes that promote the development of HIE and renal failure. Finally, the aim is to compare diagnostic and prognostic methods with the currently recommended measures. The CEUS is to be examined as a possible diagnostic imaging tool and possibly a supplement to existing diagnostic methods.

Details
Condition Perinatal Asphyxia, Hypothermia Treatment, Gestational Age Min. 36SSW
Treatment Contrast enhanced ultrasound imaging (CEUS) and post processing with ULM
Clinical Study IdentifierNCT06611254
SponsorUniversity of Erlangen-Nürnberg Medical School
Last Modified on26 September 2024

Eligibility

 Yes No Not Sure

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
Clear my responses
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