NCT06611254 Quantification of Brain and Kidney Perfusion Before, During, and After Hypothermia Treatment in Neonates With Perinatal Asphyxia Using Contrast-enhanced Ultrasound
| NCT ID | NCT06611254 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Erlangen-Nürnberg Medical School |
| Condition | Perinatal Asphyxia |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-06-24 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2024-06-24 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Ferdinand Knieling, MD
PRINCIPAL INVESTIGATOR
FAU Erlangen-Nuernberg
Frequently Asked Questions
Who can join the NCT06611254 clinical trial?
This trial is open to participants of all sexes, studying Perinatal Asphyxia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06611254 currently recruiting?
Yes, NCT06611254 is actively recruiting participants. Contact the research team at ferdinand.knieling@uk-erlangen.de for enrollment information.
Where is the NCT06611254 trial being conducted?
This trial is being conducted at Erlangen, Germany.
Who is sponsoring the NCT06611254 clinical trial?
NCT06611254 is sponsored by University of Erlangen-Nürnberg Medical School. The principal investigator is Ferdinand Knieling, MD at FAU Erlangen-Nuernberg. The trial plans to enroll 20 participants.