Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06611254
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-21
Brief Title:
Quantification of Brain and Kidney Perfusion Before During and After Hypothermia Treatment in Neonates With Perinatal Asphyxia Using Contrast-enhanced Ultrasound
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Quantification of Brain and Kidney Perfusion Before During and After Hypothermia Treatment in Neonates With Perinatal Asphyxia Using Contrast-enhanced Ultrasound
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 335C 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 treatment1 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 vessels8 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
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 335C 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 treatment1 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 vessels8 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None