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

NCT06611254 | Recruiting

• 1 other identifier: Neo_CEUS_ULM
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Asphyxia; Hypothermia Treatment; Gestational Age Min. 36SSW

Outcome Measures

Primary Outcomes (17)

• CEUS Time intensity curves

  All CEUS outcomes will be generated in order to achieve time intensity curves in contrast enhanced ultrasound analysis

  before(T1, within the first 6hours of life), during hypothermia treatment(T2, 6-78hours of life), after treatment (T3, within first week of life)

• CEUS Measurement1

  PE (Peak-Enhancement)

  before(T1, within the first 6hours of life), during hypothermia treatment(T2, 6-78hours of life), after treatment (T3, within first week of life)

• CEUS Measurement2

  WiAUC (Wash-in Area Under the Curve (AUC(TI: TTP)))

  before(T1, within the first 6hours of life), during hypothermia treatment(T2, 6-78hours of life), after treatment (T3, within first week of life)

• CEUS Measurement3

  WiAUC (Wash-in Area Under the Curve (AUC(TI: TTP)))

  before(T1, within the first 6hours of life), during hypothermia treatment(T2, 6-78hours of life), after treatment (T3, within first week of life)

• CEUS Measurement4

  RT (Rise Time)

  before(T1, within the first 6hours of life), during hypothermia treatment(T2, 6-78hours of life), after treatment (T3, within first week of life)

• CEUS Measurement5

  mTT (mean Transit Time local) (mTT-TI))

  before(T1, within the first 6hours of life), during hypothermia treatment(T2, 6-78hours of life), after treatment (T3, within first week of life)

• CEUS Measurement6

  TTP (Time to Peak)

  before(T1, within the first 6hours of life), during hypothermia treatment(T2, 6-78hours of life), after treatment (T3, within first week of life)

• CEUS Measurement7

  WiR (Wash-in-Rate )

  before(T1, within the first 6hours of life), during hypothermia treatment(T2, 6-78hours of life), after treatment (T3, within first week of life)

• CEUS Measurement8

  WiPI (Wash-in Perfusion Index (WiAUC/RT))

  before(T1, within the first 6hours of life), during hypothermia treatment(T2, 6-78hours of life), after treatment (T3, within first week of life)

• CEUS Measurement9

  WoAUC (Wash-out AUC (AUC(TTP:TO)))

  before(T1, within the first 6hours of life), during hypothermia treatment(T2, 6-78hours of life), after treatment (T3, within first week of life)

• CEUS Measurement10

  WiWoAUC (Wash-in- und Wash-out-AUC (WiAUC+WoAUC))

  before(T1, within the first 6hours of life), during hypothermia treatment(T2, 6-78hours of life), after treatment (T3, within first week of life)

• CEUS Measurement11

  FT (Fall Time - (TO-TTP))

  before(T1, within the first 6hours of life), during hypothermia treatment(T2, 6-78hours of life), after treatment (T3, within first week of life)

• CEUS Measurement12

  WOR (Wash-out-Rate) QOF (Quality Of Fit between the echo-power signal and f(t)

  before(T1, within the first 6hours of life), during hypothermia treatment(T2, 6-78hours of life), after treatment (T3, within first week of life)

• CEUS Measurement13

  QOF (Quality Of Fit between the echo-power signal and f(t)

  before(T1, within the first 6hours of life), during hypothermia treatment(T2, 6-78hours of life), after treatment (T3, within first week of life)

• Near-infrared spectroscopy

  Near-infrared spectroscopy Non-invasive measurement of oxygen saturation in tissue using a probe that is attached to the head.62 This procedure is already firmly established in the field of pediatric surgery and pediatric cardiology interventions at the University Hospital Erlangen. The probe is attached before the start of the first measurement time point and removed after the end of the third measurement time point. There is no risk of side effects.

  before(T1, within the first 6hours of life), during hypothermia treatment(T2, 6-78hours of life), after treatment (T3, within first week of life)

• Visualization and quantification of cerebral perfusion with CEUS

  CEUS imaging for cerebral perfusion in asphyxia

  before(T1, within the first 6hours of life), during hypothermia treatment(T2, 6-78hours of life), after treatment (T3, within first week of life)

• Visualization and quantification of of renal perfusion with CEUS

  CEUS imaging for renal perfusion in asphyxia

  before(T1, within the first 6hours of life), during hypothermia treatment(T2, 6-78hours of life), after treatment (T3, within first week of life)

Secondary Outcomes (12)

• CEUS and NIRS

  T1,T2,T3

• Neurological status assessment (Bayley Score)

  Month of life: 3-4 and 6-24

• MRI imaging in asphyxia

  once within first two years of life

• Comparison of the CEUS time-intensity curve between three timepoints

  T1,T2, T3

• Assessment of blood Lactate

  T1, T2, T3

Study Arms (1)

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.

Device: Contrast enhanced ultrasound imaging (CEUS) and post processing with ULM

Interventions

Contrast enhanced ultrasound imaging (CEUS) and post processing with ULM DEVICE

CEUS is a contrast based ultrasound technique and ULM (Ultrasound Localization Microscopy) is a post-processing bioinformatical method to quantify microvascular architecture and perfusion dynamics.

Neonates with perinatal asphyxia and indication for hypothermia treatment

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

One study population. Anticipated approx. n=20 neonateswith above mentioned inclusion criteria with perinatal asphyxia and inclusion criteria for hypothermia treatmentaccording to the AWMF guideline.

You may qualify if:

• 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

You may not qualify if:

• Lack of consent of at least one parent
• Pre-existing brain malformations
• Absence of the competent examiner

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

FAU Erlangen-Nuernberg

Erlangen, Bavaria, 91054, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples

Study Officials

• Ferdinand Knieling, MD

  FAU Erlangen-Nuernberg

  PRINCIPAL INVESTIGATOR

• Gregor Hanslik, MD

  FAU Erlangen-Nuernberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ferdinand Knieling, MD

CONTACT

0049 9131 85 33118; ferdinand.knieling@uk-erlangen.de

Gregor Hanslik, MD

CONTACT

0049 9131 85 33118; gregor.hanslik@uk-erlangen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Pediatric Translational Imaging Laboratory

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: September 24, 2024
• Study Start: June 24, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)