Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06018012
Status:
COMPLETED
Last Update Posted:
2023-09-01
First Post:
2023-08-18
Brief Title:
MRA and ABR as Early Predictors of Bilirubin-Induced Neurologic Dysfunction in Full-term Jaundiced Neonates
Sponsor:
Tanta University
Organization:
Tanta University
Study Overview
Official Title:
Magnetic Resonance Spectroscopy and Auditory Brain- Stem Response Audiometry as Early Predictors of Bilirubin-Induced Neurologic Dysfunction in Full-term Jaundiced Neonates
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the research was to define the role of MRS and ABR as early predictors of bilirubin-induced neurologic dysfunction BIND in full-term neonates who required intervention phototherapy or exchange transfusion
Detailed Description:
Neonatal jaundice is a prevalent condition Its typically a harmless phase that occurs as the body adjusts to bilirubin levels after birth representing a balance between its production and elimination When theres an increase in bilirubin production and a decrease in elimination infants become at risk for dangerous hyperbilirubinemia potentially leading to bilirubin encephalopathy
The range of neurological issues caused by excessive bilirubin is referred to as bilirubin-induced neurologic dysfunction Detecting this condition early is crucial to prevent irreversible brain damage Some of the neurological effects include gliosis demyelination and interference with glutamate uptake by astrocytes in the basal ganglia Magnetic resonance spectroscopy MRS is an advanced imaging technique that holds promise for identifying these metabolic changes and aiding in the diagnosis and evaluation of neonates with hyperbilirubinemia
Bilirubin neurotoxicity particularly affects the auditory system starting with the brainstem cochlear nuclei followed by the auditory nerve This damage can occur even without the classic signs of bilirubin encephalopathy and is known as auditory neuropathy spectrum disorder ANSD ANSD is characterized by abnormal auditory neural function while cochlear microphonics and otoacoustic emissions remain normal
The impact on hearing can vary from subtle issues in sound processing to complete deafness Abnormal results in auditory brainstem response ABR tests can indicate the presence of acute bilirubin encephalopathy ABE serving as the most common and earliest sign of ABE
The range of neurological issues caused by excessive bilirubin is referred to as bilirubin-induced neurologic dysfunction Detecting this condition early is crucial to prevent irreversible brain damage Some of the neurological effects include gliosis demyelination and interference with glutamate uptake by astrocytes in the basal ganglia Magnetic resonance spectroscopy MRS is an advanced imaging technique that holds promise for identifying these metabolic changes and aiding in the diagnosis and evaluation of neonates with hyperbilirubinemia
Bilirubin neurotoxicity particularly affects the auditory system starting with the brainstem cochlear nuclei followed by the auditory nerve This damage can occur even without the classic signs of bilirubin encephalopathy and is known as auditory neuropathy spectrum disorder ANSD ANSD is characterized by abnormal auditory neural function while cochlear microphonics and otoacoustic emissions remain normal
The impact on hearing can vary from subtle issues in sound processing to complete deafness Abnormal results in auditory brainstem response ABR tests can indicate the presence of acute bilirubin encephalopathy ABE serving as the most common and earliest sign of ABE
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None