Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517862
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Efficacy Safety of Oral Adjuvants to Phototherapy in Neonatal Hyperbilirubinemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Oral Zinc Sulphate and Ursodeoxycholic Acid as Adjuvants to Phototherapy in Management of Neonatal Non-Hemolytic Unconjugated Hyperbilirubinemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
Neonatal jaundice or neonatal hyperbilirubinemia is a common medical issue in the first two weeks of life causing prolonged hospitalization and readmissions It results from elevated total serum bilirubin TSB and is manifested as yellowish discoloration of the skin sclera and mucous membrane Clinical jaundice appears in about 60 of term neonates and 80 of preterm infants within the first week of life Pathologic hyperbilirubinemia occurs when bilirubin levels increase by more than 5 mgdLday or 02 mgdLhour or when jaundice lasts longer than two to three weeks in full-term infants In preterm infants unconjugated hyperbilirubinemia is of particular concern due to their permeable blood-brain barrier and underdeveloped brain Phototherapy is widely used to reduce or prevent the rise of serum unconjugated bilirubin levels and reduce the need for exchange transfusions However phototherapy has both immediate and long-term side effects and it can only decrease accumulated UCB but does not prevent its accumulation There is a growing potential to explore novel adjuvant treatments to increase bilirubin clearance decrease phototherapy duration and decrease exchange transfusion rate
Detailed Description:
Neonatal jaundice or neonatal hyperbilirubinemia is the most common medical issue in the first two weeks of life and is a frequent cause of prolonged hospitalization and readmission to the hospital after birth It results from elevated total serum bilirubin TSB and is clinically manifested as yellowish discoloration of the skin sclera and mucous membrane Increased enterohepatic circulation of indirect bilirubin is one of the elucidated mechanisms implicated in the pathophysiology of neonatal hyperbilirubinemia
Clinical jaundice appears in about 60 of term neonates and 80 of preterms within the first week of life In most cases it is a mild transient and self-limiting condition that resolves spontaneously and is referred to as physiological jaundice When bilirubin levels increase by more than 5 mgdLday or more than 02 mgdLhour or when jaundice lasts longer than two to three weeks in full-term infants pathologic hyperbilirubinemia is said to have occurred In preterm infants unconjugated hyperbilirubinemia is of particular concern given that their blood-brain barrier is more permeable and their underdeveloped brain is more susceptible to bilirubin-induced neurotoxicity
Scavenging unconjugated plasma bilirubin can be done conveniently non-invasively and effectively by phototherapy Phototherapy is universally recognized as the mainstay for the treatment of neonatal jaundice and is widely used in neonatal units and postnatal wards It is a safe and effective method for decreasing or preventing the rise of serum unconjugated bilirubin levels and it reduces the need for exchange transfusions in neonates
However phototherapy has both immediate and long-term side effects such as rash bronze baby syndrome and circadian rhythm modification This is coupled with social side effects like parental concern because of the infants increased hospitalization broken mother-infant attachment and high cost of care Moreover phototherapy can only decrease already accumulated UCB but does not prevent its accumulation Exchange transfusion therapy which is generally performed after the failure of phototherapy may lead to severe complications such as embolism sepsis necrotizing enterocolitis or even death
Consequently there is a growing potential to explore novel adjuvant treatments that can help to increase bilirubin clearance decrease phototherapy duration and decrease exchange transfusion rate
One of the methods used to treat indirect hyperbilirubinemia is to use a zinc solution Studies have shown that chronic or acute use of zinc salts can reduce serum bilirubin levels by inhibiting the enterohepatic cycle of indirect bilirubin Oral administration of zinc Zn sulfate increases bilirubin excretion and decreases its serum level
Oral administration of Zn salts is possible in two dose ranges low 10 mgday and high 11-20 mgday Given that some of the medication is absorbed in the proximal ileum giving a high dose may be desirable Zn salts are safe and studies treating several children and newborns with diarrhea measles pneumonia the common cold and malaria have demonstrated the safety of oral Zn sulfate administration Studies conducted on the effectiveness of Zn salts on serum indirect bilirubin levels in newborns have yielded different results all calling for further research Additionally neonates with hyperbilirubinemia appear to have lower serum Zn levels than other well-term neonates
The efficacy of ursodeoxycholic acid as an adjuvant to phototherapy has also been examined in a few studies Ursodeoxycholic acid UDCA or ursodiol is a bile acid commonly used to manage cholestatic liver disease UDCA helps in improving endogenous bile secretion reducing the reducing the displacement of more toxic components of endogenous bile acids and reducing enterohepatic circulation Because of its anti-apoptotic anti-inflammatory and antioxidant characteristics UDCA also has hepatoprotective and neuroprotective effects
Although UDCA is an off-label treatment in neonates it is widely used in conjugated hyperbilirubinemia and liver disorders UDCA has also been investigated for its possible role in indirect hyperbilirubinemia It is thought to function by inhibiting the reabsorption of bilirubin from the intestines UDCA is often tolerated well In studies on healthy-term neonates ill neonates and neonates with G6PD deficiency UDCA was reported to be useful in shortening the length of phototherapy
Clinical jaundice appears in about 60 of term neonates and 80 of preterms within the first week of life In most cases it is a mild transient and self-limiting condition that resolves spontaneously and is referred to as physiological jaundice When bilirubin levels increase by more than 5 mgdLday or more than 02 mgdLhour or when jaundice lasts longer than two to three weeks in full-term infants pathologic hyperbilirubinemia is said to have occurred In preterm infants unconjugated hyperbilirubinemia is of particular concern given that their blood-brain barrier is more permeable and their underdeveloped brain is more susceptible to bilirubin-induced neurotoxicity
Scavenging unconjugated plasma bilirubin can be done conveniently non-invasively and effectively by phototherapy Phototherapy is universally recognized as the mainstay for the treatment of neonatal jaundice and is widely used in neonatal units and postnatal wards It is a safe and effective method for decreasing or preventing the rise of serum unconjugated bilirubin levels and it reduces the need for exchange transfusions in neonates
However phototherapy has both immediate and long-term side effects such as rash bronze baby syndrome and circadian rhythm modification This is coupled with social side effects like parental concern because of the infants increased hospitalization broken mother-infant attachment and high cost of care Moreover phototherapy can only decrease already accumulated UCB but does not prevent its accumulation Exchange transfusion therapy which is generally performed after the failure of phototherapy may lead to severe complications such as embolism sepsis necrotizing enterocolitis or even death
Consequently there is a growing potential to explore novel adjuvant treatments that can help to increase bilirubin clearance decrease phototherapy duration and decrease exchange transfusion rate
One of the methods used to treat indirect hyperbilirubinemia is to use a zinc solution Studies have shown that chronic or acute use of zinc salts can reduce serum bilirubin levels by inhibiting the enterohepatic cycle of indirect bilirubin Oral administration of zinc Zn sulfate increases bilirubin excretion and decreases its serum level
Oral administration of Zn salts is possible in two dose ranges low 10 mgday and high 11-20 mgday Given that some of the medication is absorbed in the proximal ileum giving a high dose may be desirable Zn salts are safe and studies treating several children and newborns with diarrhea measles pneumonia the common cold and malaria have demonstrated the safety of oral Zn sulfate administration Studies conducted on the effectiveness of Zn salts on serum indirect bilirubin levels in newborns have yielded different results all calling for further research Additionally neonates with hyperbilirubinemia appear to have lower serum Zn levels than other well-term neonates
The efficacy of ursodeoxycholic acid as an adjuvant to phototherapy has also been examined in a few studies Ursodeoxycholic acid UDCA or ursodiol is a bile acid commonly used to manage cholestatic liver disease UDCA helps in improving endogenous bile secretion reducing the reducing the displacement of more toxic components of endogenous bile acids and reducing enterohepatic circulation Because of its anti-apoptotic anti-inflammatory and antioxidant characteristics UDCA also has hepatoprotective and neuroprotective effects
Although UDCA is an off-label treatment in neonates it is widely used in conjugated hyperbilirubinemia and liver disorders UDCA has also been investigated for its possible role in indirect hyperbilirubinemia It is thought to function by inhibiting the reabsorption of bilirubin from the intestines UDCA is often tolerated well In studies on healthy-term neonates ill neonates and neonates with G6PD deficiency UDCA was reported to be useful in shortening the length of phototherapy
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