Perinatal AsphyxiaNCT06611254
Quantification of Brain and Kidney Perfusion Before, During, and After Hypothermia Treatment in Neonates With Perinatal Asphyxia Using Contrast-enhanced Ultrasound
An observational study of Perinatal Asphyxia and Hypothermia Treatment, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Perinatal Asphyxia, Hypothermia Treatment, Gestational Age Min. 36SSW
- What is being tested?
- Contrast enhanced ultrasound imaging (CEUS) and post processing with ULM
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 24 Jun 2024to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- Lack of consent of at least one parent
- Pre-existing brain malformations
- Absence of the competent examiner
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
FAU Erlangen-Nuernberg
Erlangen, Bavaria, 91054
Ferdinand Knieling, MD, 0049 9131 85 33118, ferdinand.knieling@uk-erlangen.de
Ferdinand Knieling, MD
About this study
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.
Read the detailed description
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.
- Being tested
- Contrast enhanced ultrasound imaging (CEUS) and post processing with ULM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast enhanced ultrasound imaging (CEUS) and post processing with ULMDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Contrast enhanced ultrasound imaging (CEUS) and post processing with ULM |
What is being measured
The primary outcome is the main question the study is designed to answer.
CEUS Time intensity curves
All CEUS outcomes will be generated in order to achieve time intensity curves in contrast enhanced ultrasound analysis
Measured: 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)
Measured: 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)))
Measured: 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)))
Measured: 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)
Measured: 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))
Measured: 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)
Measured: 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 )
Measured: 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))
Measured: 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)))
Measured: 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))
Measured: 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))
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Correlation coefficient (R) between CEUS curve and NIRS
Measured: 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"
Measured: Month of life: 3-4 and 6-24
MRI imaging in asphyxia
MRI Weeke Score
Measured: once within first two years of life
Comparison of the CEUS time-intensity curve between three timepoints
CEUS curve at T1,T2, T3
Measured: T1,T2, T3
Assessment of blood Lactate
Lactate (mmol/l)
Measured: T1, T2, T3
EEG signs of seizures
Number (n) of ETPs in EEG
Measured: T1 -T3 and through study completion
EEG activity
frequency EEG (Hz)
Measured: T1 -T3 and through study completion
Assessment of renal function GFR
GFR (ml/min/1,73 m2)
Measured: T1 -T3 and through study completion, an average of 3 years
Assessment of renal function urea
urea (mg/dl)
Measured: T1 -T3 and through study completion, an average of 3 years
Assessment of renal function urinary status
standardized urinary status
Measured: T1 -T3 and through study completion
Assesment of renal function kreatininekinase
kreatininekinase (U/l)
Measured: T1, T2, T3
Assessment of metabolic LDH
LDH (U/l)
Measured: T1, T2, T3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start24 Jun 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal AsphyxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferdinand Knieling, University of Erlangen-Nürnberg Medical School
- Investigators
- Ferdinand Knieling, MD, Principal investigator, FAU Erlangen-NuernbergGregor Hanslik, MD, Principal investigator, FAU Erlangen-Nuernberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611254
- Sponsor's protocol ID
- Neo_CEUS_ULM
- Status last verified
- Sep 2024
- First submitted
- 21 Jun 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Brain and Kidney Perfusion Before, During, and After Hypothermia Treatment in Neonates With Perinatal Asphyxia Using Contrast-enhanced Ultrasound
- ClinicalTrials.gov ID
- NCT06611254
- Acronym / sponsor ID
- Neo_CEUS_ULM
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates with perinatal asphyxia and indication for hypothermia treatment | – | Device: Contrast enhanced ultrasound imaging (CEUS) and post processing with ULMIncluded 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. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (3 listed)
- Lack of consent of at least one parent
- Pre-existing brain malformations
- Absence of the competent examiner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast enhanced ultrasound imaging (CEUS) and post processing with ULMCEUS is a contrast based ultrasound technique and ULM (Ultrasound Localization Microscopy) is a post-processing bioinformatical method to quantify microvascular architecture and perfusion dynamics. | Device | Neonates with perinatal asphyxia and indication for hypothermia treatment |
Primary outcome
CEUS Time intensity curves
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)
All CEUS outcomes will be generated in order to achieve time intensity curves in contrast enhanced ultrasound analysis
CEUS Measurement1
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)
PE (Peak-Enhancement)
CEUS Measurement2
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)
WiAUC (Wash-in Area Under the Curve (AUC(TI: TTP)))
CEUS Measurement3
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)
WiAUC (Wash-in Area Under the Curve (AUC(TI: TTP)))
CEUS Measurement4
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)
RT (Rise Time)
CEUS Measurement5
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)
mTT (mean Transit Time local) (mTT-TI))
CEUS Measurement6
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)
TTP (Time to Peak)
CEUS Measurement7
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)
WiR (Wash-in-Rate )
CEUS Measurement8
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)
WiPI (Wash-in Perfusion Index (WiAUC/RT))
CEUS Measurement9
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)
WoAUC (Wash-out AUC (AUC(TTP:TO)))
CEUS Measurement10
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)
WiWoAUC (Wash-in- und Wash-out-AUC (WiAUC+WoAUC))
CEUS Measurement11
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)
FT (Fall Time - (TO-TTP))
CEUS Measurement12
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)
WOR (Wash-out-Rate) QOF (Quality Of Fit between the echo-power signal and f(t)
CEUS Measurement13
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)
QOF (Quality Of Fit between the echo-power signal and f(t)
Near-infrared spectroscopy
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 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.
Visualization and quantification of cerebral perfusion with CEUS
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 imaging for cerebral perfusion in asphyxia
Visualization and quantification of of renal perfusion with CEUS
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 imaging for renal perfusion in asphyxia
12 secondary outcomes
CEUS and NIRS
Time frame: T1,T2,T3
Neurological status assessment (Bayley Score)
Time frame: Month of life: 3-4 and 6-24
MRI imaging in asphyxia
Time frame: once within first two years of life
Comparison of the CEUS time-intensity curve between three timepoints
Time frame: T1,T2, T3
Assessment of blood Lactate
Time frame: T1, T2, T3
EEG signs of seizures
Time frame: T1 -T3 and through study completion
EEG activity
Time frame: T1 -T3 and through study completion
Assessment of renal function GFR
Time frame: T1 -T3 and through study completion, an average of 3 years
Assessment of renal function urea
Time frame: T1 -T3 and through study completion, an average of 3 years
Assessment of renal function urinary status
Time frame: T1 -T3 and through study completion
Assesment of renal function kreatininekinase
Time frame: T1, T2, T3
Assessment of metabolic LDH
Time frame: T1, T2, T3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ferdinand Knieling, MD principal investigator
FAU Erlangen-Nuernberg
Gregor Hanslik, MD principal investigator
FAU Erlangen-Nuernberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perinatal Asphyxia and Hypothermia Treatment, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ferdinand Knieling, MD (0049 9131 85 33118, ferdinand.knieling@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CEUS Time intensity curves (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)). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.