Monitoring brain and kidney blood flow in newborns with asphyxia during hypothermia treatment
Quantification of Brain and Kidney Perfusion Before, During, and After Hypothermia Treatment in Neonates With Perinatal Asphyxia Using Contrast-enhanced Ultrasound
This study is testing how blood flow in the brains and kidneys of newborns with asphyxia changes during and after cooling treatment to see how it affects their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Sex | All |
| Sponsor | University of Erlangen-Nürnberg Medical School Academic / other |
| Locations | 1 site (Erlangen, Bavaria) |
| Trial ID | NCT06611254 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are neonates with severe acidosis and clinical signs of moderate to severe encephalopathy who are eligible for hypothermia treatment.
Not a fit: Patients who do not meet the inclusion criteria for hypothermia treatment or have a postnatal age greater than 6 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management and outcomes of neonates with perinatal asphyxia by providing better monitoring of organ perfusion during hypothermia treatment.
How similar studies have performed: While the use of hypothermia treatment is established, the specific application of CEUS and ULM for monitoring organ perfusion in this context is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Erlangen, Bavaria
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.