Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603753
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-07
Brief Title:
Role of Serum BA Ratio Compared to TSB for Early Prediction of Bilirubin-induced Neurological Dysfunction BIND
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Use of Serum BilirubinAlbumin Ratio for Early Prediction of Bilirubin Induced Neurological Dysfunction
Status:
NOT_YET_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:
The aim of this study is to evaluate serum bilirubinalbumin BA ratio compared to total serum bilirubin TSB for early prediction of bilirubin-induced neurological dysfunction BIND
Detailed Description:
Introduction Neonatal hyperbilirubinemia is a common problem in neonates Approximately 60 of term and 80 of preterm babies develop jaundice in the first week of life and about 10 of breastfed babies are still jaundiced at 1 month
Jaundice due to either indirect unconjugated or direct conjugated bilirubin within the first 24 h of life should be taken seriously Early identification and proper management are needed to prevent the serious neurological complications
When the total serum bilirubin TSB rises above the 95th percentile for age high-risk zone entry of unconjugated bilirubin into the brain can cause both short-term and long-term neurological dysfunctions bilirubin encephalopathy The increased level of bilirubin is detrimental for nervous system especially damage the basal ganglia cerebellum and brainstem thus resulting in bilirubin-induced neurological dysfunction BIND
Bilirubin-induced neurologic dysfunction BIND is the term applied to the spectrum of neurologic abnormalities associated with hyperbilirubinemia It can be further divided into characteristic signs and symptoms that appear in the early stages acute and those that evolve over a prolonged period chronic Signs and symptoms of BIND include tone abnormalities such as hypotonia hypertonia retrocollis and opisthotonos in association with varying degrees of drowsiness lethargy decreased feeding and irritability
BIND was also associated with Kernicterus leading to devastating disability including athetoid cerebral palsy speech and hearing impairment BIND in neonates is a significant cause of death or lifelong disability including cerebral palsy CP and auditory disorders
The earliest signs and symptoms of BIND are nonspecific therefore may be easily missed thus an early diagnostic tool is required BIND score is a scoring system in which characteristics of mental state muscle tone and cry are grouped into three levels of increasing abnormality stage IA minimal signs stage IB progressive but reversible with treatment stage II advanced and largely irreversible but may be significantly decreased by treatment
The pathogenesis of BIND is multifactorial and includes interaction between the level of unconjugated bilirubin free bilirubin bilirubin bound to albumin bilirubin passed through brain blood barrier and nerves damage Although 999 of unconjugated bilirubin in the circulation is bound to albumin a relatively small fraction only less than 01 remains unbound free bilirubin and it can go into the brain across an intact blood brain barrier BBB
There is currently no method available for measuring free bilirubin concentrations accurately in plasma or serum therefore adjunct measurements of albumin concentration and bilirubin albumin ratio BA may provide more insight into the likelihood of bilirubin-induced encephalopathy The BA ratio is considered a surrogate parameter for free bilirubin and an interesting additional parameter in the management of hyperbilirubinemia Few studies suggested the utilization of BA ratios as a predictor for bilirubin-induced neurotoxicity
Jaundice due to either indirect unconjugated or direct conjugated bilirubin within the first 24 h of life should be taken seriously Early identification and proper management are needed to prevent the serious neurological complications
When the total serum bilirubin TSB rises above the 95th percentile for age high-risk zone entry of unconjugated bilirubin into the brain can cause both short-term and long-term neurological dysfunctions bilirubin encephalopathy The increased level of bilirubin is detrimental for nervous system especially damage the basal ganglia cerebellum and brainstem thus resulting in bilirubin-induced neurological dysfunction BIND
Bilirubin-induced neurologic dysfunction BIND is the term applied to the spectrum of neurologic abnormalities associated with hyperbilirubinemia It can be further divided into characteristic signs and symptoms that appear in the early stages acute and those that evolve over a prolonged period chronic Signs and symptoms of BIND include tone abnormalities such as hypotonia hypertonia retrocollis and opisthotonos in association with varying degrees of drowsiness lethargy decreased feeding and irritability
BIND was also associated with Kernicterus leading to devastating disability including athetoid cerebral palsy speech and hearing impairment BIND in neonates is a significant cause of death or lifelong disability including cerebral palsy CP and auditory disorders
The earliest signs and symptoms of BIND are nonspecific therefore may be easily missed thus an early diagnostic tool is required BIND score is a scoring system in which characteristics of mental state muscle tone and cry are grouped into three levels of increasing abnormality stage IA minimal signs stage IB progressive but reversible with treatment stage II advanced and largely irreversible but may be significantly decreased by treatment
The pathogenesis of BIND is multifactorial and includes interaction between the level of unconjugated bilirubin free bilirubin bilirubin bound to albumin bilirubin passed through brain blood barrier and nerves damage Although 999 of unconjugated bilirubin in the circulation is bound to albumin a relatively small fraction only less than 01 remains unbound free bilirubin and it can go into the brain across an intact blood brain barrier BBB
There is currently no method available for measuring free bilirubin concentrations accurately in plasma or serum therefore adjunct measurements of albumin concentration and bilirubin albumin ratio BA may provide more insight into the likelihood of bilirubin-induced encephalopathy The BA ratio is considered a surrogate parameter for free bilirubin and an interesting additional parameter in the management of hyperbilirubinemia Few studies suggested the utilization of BA ratios as a predictor for bilirubin-induced neurotoxicity
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