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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
View:

• 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

Locations
Other Locations
Germany
FAU Erlangen-Nuernberg
RECRUITING
Erlangen
Contact Information
Primary
Ferdinand Knieling, MD
ferdinand.knieling@uk-erlangen.de
0049 9131 85 33118
Backup
Gregor Hanslik, MD
gregor.hanslik@uk-erlangen.de
0049 9131 85 33118
Time Frame
Start Date: 2024-06-24
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 20
Treatments
Neonates with perinatal asphyxia and indication for hypothermia treatment
Included will be neonates with perinatal asphyxia that get an indication for hypothermia treatment (severe azidosis and signs of encephalopathy and under 6h of age and \>36 gest. weeks). They will be monitored with CEUS/ULM at three different time points (T1: within first 6h of life/before hypothermia treatment, T2 = during hypothermia treatment/6-78h of life, T3 = after hypothermia treatment/within first week of life.
Related Therapeutic Areas
Sponsors
Leads: University of Erlangen-Nürnberg Medical School

This content was sourced from clinicaltrials.gov