An observational study in Perinatal Asphyxia, Hypothermia Treatment and Gestational Age Min. 36SSW, sponsored by University of Erlangen-Nürnberg Medical School. Recruiting at 1 site in Germany. Per ClinicalTrials.gov, last updated 2024-09-24.
Sponsored by University of Erlangen-Nürnberg Medical School · Observational
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.
Perinatal asphyxia (PA) is the reduced supply of oxygen to vital organs during or immediately after birth. PA is one of the most common causes of neonatal mortality in full-term infants worldwide and of hypoxic-ischemic encephalopathy (HIE) with subsequent neurological deficits (spastic cerebral palsy). In addition to brain damage, perinatal asphyxia often leads to dysfunction of other organs. It is not uncommon for this to be accompanied by transient renal failure.
Hypothermia treatment is an established therapeutic measure for neuroprotection in clinical indications of HIE. This involves lowering the core body temperature of affected children to 33.5°C for 72 hours. The therapeutic effect is thought to be due to multifactorial mechanisms, including a reduction in endothelial dysfunction, reduced excretion of free radicals and attenuation of the inflammatory cascade.
In the guidelines for hypothermia treatment in neonatal asphyxia, regular ultrasound examinations are prescribed to clarify damage to the central nervous system (CNS) before, during and after hypothermia treatment.1 In infants, transfontal ultrasound makes it possible to visualize brain structures, vessels and their flow velocities.
The intravenous use of ultrasound contrast enhancers as an aid also opens up the possibility of recording the tissue perfusion of the CNS and kidneys, including the smallest vessels.8 This could provide significantly more information compared to conventional methods and expand our knowledge of the pathophysiology and individual status of tissue perfusion in patients.
For example, two studies at Erlangen University Hospital have successfully used contrast-enhanced ultrasound (CEUS) with the contrast agent known as SonoVue® to visualize postoperative perfusion of the brain after pediatric cardiac surgery.
In this clinical study, the new CEUS measurement and imaging technique will be used before, during and after hypothermia treatment in neonates with asphyxia. A contrast agent (SonoVue®) will be administered during the routine ultrasound examination and improved tissue visualization will be achieved. The aim is to gain new insights into brain and kidney perfusion as part of the treatment and to better assess the extent of organ damage in the individual patient through more specific vascular imaging. Improved visualization and assessment of the end-stream area will provide information on processes that promote the development of HIE and renal failure. Finally, the aim is to compare diagnostic and prognostic methods with the currently recommended measures. The CEUS is to be examined as a possible diagnostic imaging tool and possibly a supplement to existing diagnostic methods.
39 studies on the registry are indexed under Asphyxia; 7 are open to participants now.
This study's planned enrollment of 20 is below the median of 400 across 15 observational studies indexed under Asphyxia.
Browse Asphyxia studies →University of Erlangen-Nürnberg Medical School is the lead sponsor of 276 studies on the registry; 52 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Time 1 (before the start of hypothermia treatment)
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
Exclusion Criteria:
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
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.
CEUS Time intensity curves
All CEUS outcomes will be generated in order to achieve time intensity curves in contrast enhanced ultrasound analysis
Time frame: 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)
Time frame: 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)))
Time frame: 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)))
Time frame: 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)
Time frame: 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))
Time frame: 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)
Time frame: 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 )
Time frame: 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))
Time frame: 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)))
Time frame: 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))
Time frame: 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))
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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 and NIRS
Correlation coefficient (R) between CEUS curve and NIRS
Time frame: T1,T2,T3
Neurological status assessment (Bayley Score)
Neurological status of the patients will be assessed by the score "Bayley Scales of Infant and Toddler Development"
Time frame: Month of life: 3-4 and 6-24
MRI imaging in asphyxia
MRI Weeke Score
Time frame: once within first two years of life
Comparison of the CEUS time-intensity curve between three timepoints
CEUS curve at T1,T2, T3
Time frame: T1,T2, T3
Assessment of blood Lactate
Lactate (mmol/l)
Time frame: T1, T2, T3
EEG signs of seizures
Number (n) of ETPs in EEG
Time frame: T1 -T3 and through study completion
EEG activity
frequency EEG (Hz)
Time frame: T1 -T3 and through study completion
Assessment of renal function GFR
GFR (ml/min/1,73 m2)
Time frame: T1 -T3 and through study completion, an average of 3 years
Assessment of renal function urea
urea (mg/dl)
Time frame: T1 -T3 and through study completion, an average of 3 years
Assessment of renal function urinary status
standardized urinary status
Time frame: T1 -T3 and through study completion
Assesment of renal function kreatininekinase
kreatininekinase (U/l)
Time frame: T1, T2, T3
Assessment of metabolic LDH
LDH (U/l)
Time frame: T1, T2, T3
Plan to share: No
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