Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451900
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2024-03-11
Brief Title:
Role of Fenofibrate in Neonatal Jaundice
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Prophylactic Role of Fenofibrate in Neonatal Jaundice
Status:
COMPLETED
Status Verified Date:
2024-06
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:
Fenofibrate appears to be an effective and safe drug for the treatment of neonatal hyperbilirubinemia It has been proven that it decreases the duration of phototherapy and thus shortens the length of hospital stay
This study was performed to study the prophylactic role of fenofibrate in prevention of neonatal jaundice
This study was performed to study the prophylactic role of fenofibrate in prevention of neonatal jaundice
Detailed Description:
Neonatal jaundice is a common disease in neonates Based on current statistics 60 of term neonates and 80 of preterm neonates suffer from jaundice during the first week of birth The normal bilirubin level of the umbilical cord is 1-3 mgdL which increases to 5-6 mgdL on the second to fourth days after birth and decreases to less than 2 mgdL on the 5th to 7th days after birth
Destruction of red blood cell and its hemoglobin component produces bilirubin which is then conjugated to a soluble form and excreted In neonates this becomes more significant because of high red cell mass and relative immaturity for bilirubin conjugation
Free bilirubin deposits in the skin and mucous membranes and produces jaundice It may also deposit in the brain where it has been implicated in causing transient dysfunction and occasionally permanent neuronal damage
Every year a huge hospital cost is imposed on parents for the treatment of neonatal jaundice Moreover it leads to the mother-child separation and subsequent mental health problems Proven treatments for jaundice include phototherapy and blood exchange transfusion in which each one has its own complications medication has also been used to prevent and treat neonatal jaundice Including IVIG protoporphyrin phenobarbital and fenofibrate
Fibrates have been used for several years as a hypolipidemic drug in adultsThey exert their hypolipidemic activity through peroxisome proliferator- activated receptor activation The value of this mechanism in the reduction of bile acid synthesis had been demonstrated by experimental study of cindrouk and colleagues Fibrates also increase bilirubin conjugation and excretion via induction of glucuronyl transferase activity Its potency to induce bilirubin conjugation is very high Fibrates are aclass of phenoxy iso butyric acid derivatives including clofibrate and fenofibrate Fenofibrate is one of the fibrates it has inducing effect on glucuronyl transferase activity it increases bilirubin conjugation and excretion making it possible to be used in the treatment of neonatal jaundice via influencing bilirubin metabolism Fenofibrate is very similar to clofibrate in its action However it is simply more accessible and has more safety profile therefore it is much safer to be given to children than clofibrate Fenofibrate has been used in treatment of neonatal jaundice the researchers aim to explore its efficiency as a prophylactic agent in neonates with neonatal jaundice not reaching the level of phototherapy
Destruction of red blood cell and its hemoglobin component produces bilirubin which is then conjugated to a soluble form and excreted In neonates this becomes more significant because of high red cell mass and relative immaturity for bilirubin conjugation
Free bilirubin deposits in the skin and mucous membranes and produces jaundice It may also deposit in the brain where it has been implicated in causing transient dysfunction and occasionally permanent neuronal damage
Every year a huge hospital cost is imposed on parents for the treatment of neonatal jaundice Moreover it leads to the mother-child separation and subsequent mental health problems Proven treatments for jaundice include phototherapy and blood exchange transfusion in which each one has its own complications medication has also been used to prevent and treat neonatal jaundice Including IVIG protoporphyrin phenobarbital and fenofibrate
Fibrates have been used for several years as a hypolipidemic drug in adultsThey exert their hypolipidemic activity through peroxisome proliferator- activated receptor activation The value of this mechanism in the reduction of bile acid synthesis had been demonstrated by experimental study of cindrouk and colleagues Fibrates also increase bilirubin conjugation and excretion via induction of glucuronyl transferase activity Its potency to induce bilirubin conjugation is very high Fibrates are aclass of phenoxy iso butyric acid derivatives including clofibrate and fenofibrate Fenofibrate is one of the fibrates it has inducing effect on glucuronyl transferase activity it increases bilirubin conjugation and excretion making it possible to be used in the treatment of neonatal jaundice via influencing bilirubin metabolism Fenofibrate is very similar to clofibrate in its action However it is simply more accessible and has more safety profile therefore it is much safer to be given to children than clofibrate Fenofibrate has been used in treatment of neonatal jaundice the researchers aim to explore its efficiency as a prophylactic agent in neonates with neonatal jaundice not reaching the level of phototherapy
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?:
False
Is an FDA AA801 Violation?:
None