Monitoring brain and kidney blood flow in newborns with asphyxia during hypothermia treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the vascular dynamics in the brains and kidneys of neonates suffering from perinatal asphyxia using contrast-enhanced ultrasound (CEUS) and ultrasound localization microscopy (ULM). The study will monitor these parameters before, during, and after hypothermia treatment, which is a standard neuroprotective measure for infants with hypoxic-ischemic encephalopathy. By utilizing advanced imaging techniques, the study seeks to provide detailed insights into organ perfusion and potential damage caused by asphyxia. The findings could enhance understanding of the effects of hypothermia on vital organ function in affected neonates.

Why it matters

Who can join: the full rules

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

Where it's running

• FAU Erlangen-Nuernberg
  Erlangen, Bavaria, Germany Recruiting

Study contacts

• Principal investigator: Ferdinand Knieling, MD — FAU Erlangen-Nuernberg
• Study coordinator: Ferdinand Knieling, MD
• Email: ferdinand.knieling@uk-erlangen.de
• Phone: 0049 9131 85 33118

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.