Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06346743
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-29
Brief Title:
Comparison of Effects of Fenofibrate Adjuvant Therapy Versus Conventional Phototherapy in Neonatal Jaundice
Sponsor:
Muhammad Zark
Organization:
Services Institute of Medical Sciences Pakistan
Study Overview
Official Title:
Comparison of Effects of Fenofibrate Adjuvant Therapy Versus Conventional Phototherapy in Treatment of Neonatal Exaggerated Hyperbilirubinemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
Neonatal jaundice has significant importance in neonatal morbidity and mortality world-wide Though phototherapy has a relentless use in neonatal jaundice its cumbersome side effects and the physical separation of baby from the mother eventually result as increase in days of hospitalization adding to the mental anguish of the parents This study is conducted to observe the reduction of serum bilirubin level in neonates treated with Fenofibrate as an adjuvant to phototherapy in treatment of exaggerated physiological hyperbilirubinemia After informed consent single dose of Fenofibrate will be given to the group A intervention group and Group B non-intervention will only be given phototherapy Then every 24-hourly sample for serum bilirubin will be sent for lab analysis for 3 days A randomized control trial is conducted and later on the data will be analyzed in the SPSS 26 Quantitative variables like age will be presented as mean SD Qualitative variables like gender will be presented as percentage and frequency Comparison of two groups intervention group and non-intervention group apply independent sample t-test P value 005 will be taken as significant Limitation of the proposed study includes limited sample size study population limited to only one hospital and no follow-up in plan If the role of Fenofibrate is established in the management of exaggerated physiological hyperbilirubinemia in newborns it will be beneficial to minimize the risk of the complications rapid regression of hyperbilirubinemia shortening the length of hospital stay
Detailed Description:
Neonatal jaundice has significant importance in neonatal morbidity and mortality worldwide Bilirubin is an antioxidant against the free radical which is circulating in neonatal biological system Elevation in the serum bilirubin levels readily manifest as jaundice in newborns and this could be attributed to the physiological immaturity of the hepato-biliary system in the neonates Apart from this increased bilirubin production less effective binding and transportation inefficient conjugation and excretion and increased entero-hepatic circulation make a newborn vulnerable for hyperbilirubinemia Prabha et al 2020
Various studies have shown that risk factors for hyperbilirubinemia include low birth weight breastfeeding neonatal infection premature rupture of membrane male gender East Asian race and bleeding during the first trimester of pregnancy Indirect hyperbilirubinemia is dangerous and can cause kernicterus ABO and Rh incompatibility sepsis breast milk hypothyroidism deficiency of a particular enzyme eg glucose-6-phosphate dehydrogenase G6PD Gilberts syndrome and hypertrophic pyloric stenosis cause indirect hyperbilirubinemia Watchko et al 2018
Management of neonatal jaundice includes identification of neonates at risk evaluating the underlying cause of pathological hyperbilirubinemia deciding the thresholds for initiating and stopping treatment and following up of neonates with severe hyperbilirubinemia Phototherapy remains as the principal modality of treatment in treating severe hyperbilirubinemia where light of blue green spectrum with the wavelength corresponding with peak absorption by bilirubin 450-460nm is used Though phototherapy has a relentless use in neonatal jaundice its cumbersome side effects and the physical separation of baby from the mother eventually result as increase in days of hospitalization adding to the mental anguish of the parents Prabha et al 2020
The pharmacological treatment now under trial for hyperbilirubinemia are metalloporphyrins penicillamine phenobarbitate zinc sulfate and fibrates Fibrates induces bilirubin conjugation much more readily and effectively It converts unconjugated bilirubin to conjugated bilirubin thereby hasten its clearance Fenofibrate as an adjuvant to phototherapy in term neonate with pathological jaundice is well tolerated and associated with significant reduction of serum bilirubin levels a shorter duration of phototherapy shorter hospital stay and higher frequency of exclusive breast-feeding without significant adverse effects in either the single or double dosage Awad et al 2020 In a systemic review the results of the five studies showed the significant effect of Fenofibrate as adjuvant therapy on reducing TSB level the meta-analysis failed to show the same result in the study groups Zamiri et al 2020 Fenofibrate as an adjuvant to phototherapy in neonates with hyperbilirubinemia is associated with significant reduction of serum bilirubin levels Khafaga et al 2022 The present study is to compare the effects of Fenofibrate adjuvant to phototherapy with conventional phototherapy for exaggerated neonatal hyperbilirubinemia in the form of bilirubin reduction duration of phototherapy hospital stay observation of side-effects
Administration of a single dose of fenofibrate as an adjunct along with phototherapy to neonates showed a significant reduction of serum bilirubin and duration of phototherapy The duration was shorter in the fenofibrate group in comparison to the control group No side effects of fenofibrate were observed after a single dose administration Islam et al 2021 Newborns admitted in neonatal units of pediatric medicine unit I Services Hospital Lahore and fulfilling the inclusion exclusion criteria will be the study subject The patients will be divided randomly into two groups ie group A intervention and group B non-intervention Randomization will be performed by using computer generated numbers
The parentguardian of the neonate will be informed about the study verbally and informed consent will be taken The demographic data will be obtained detailed history regarding symptoms onset of disease duration of illness progression and medication will be taken General physical examination and systemic examination will be carried out
In babies with jaundice clothes will be taken off but eyes and genitalia will be covered Baby will be kept under phototherapy at baby-to-light distance of 20-40 cm Gomella ed 2013 with changing position every 2 hourly to expose as much part as possible Single dose of Fenofibrate will be given to the group A intervention group at dose of 10mgKg Al-Asy et al 2015 Group B non-intervention will only be given phototherapy Then every 24-hourly sample for serum bilirubin will be sent for lab analysis for 3 days Fenofibrate is readily available in market as 200mg 67mg generic capsule which will be diluted with sterile distilled water in syringe dropper calculated amount of dose will be given orally
Outcome of this study will be measured by number of days needed for serum bilirubin to decrease below phototherapy range in both groups If the role of Fenofibrate is established in the management of exaggerated physiological hyperbilirubinemia in newborns it will be beneficial to minimize the risk of the complications off prolong phototherapy
Various studies have shown that risk factors for hyperbilirubinemia include low birth weight breastfeeding neonatal infection premature rupture of membrane male gender East Asian race and bleeding during the first trimester of pregnancy Indirect hyperbilirubinemia is dangerous and can cause kernicterus ABO and Rh incompatibility sepsis breast milk hypothyroidism deficiency of a particular enzyme eg glucose-6-phosphate dehydrogenase G6PD Gilberts syndrome and hypertrophic pyloric stenosis cause indirect hyperbilirubinemia Watchko et al 2018
Management of neonatal jaundice includes identification of neonates at risk evaluating the underlying cause of pathological hyperbilirubinemia deciding the thresholds for initiating and stopping treatment and following up of neonates with severe hyperbilirubinemia Phototherapy remains as the principal modality of treatment in treating severe hyperbilirubinemia where light of blue green spectrum with the wavelength corresponding with peak absorption by bilirubin 450-460nm is used Though phototherapy has a relentless use in neonatal jaundice its cumbersome side effects and the physical separation of baby from the mother eventually result as increase in days of hospitalization adding to the mental anguish of the parents Prabha et al 2020
The pharmacological treatment now under trial for hyperbilirubinemia are metalloporphyrins penicillamine phenobarbitate zinc sulfate and fibrates Fibrates induces bilirubin conjugation much more readily and effectively It converts unconjugated bilirubin to conjugated bilirubin thereby hasten its clearance Fenofibrate as an adjuvant to phototherapy in term neonate with pathological jaundice is well tolerated and associated with significant reduction of serum bilirubin levels a shorter duration of phototherapy shorter hospital stay and higher frequency of exclusive breast-feeding without significant adverse effects in either the single or double dosage Awad et al 2020 In a systemic review the results of the five studies showed the significant effect of Fenofibrate as adjuvant therapy on reducing TSB level the meta-analysis failed to show the same result in the study groups Zamiri et al 2020 Fenofibrate as an adjuvant to phototherapy in neonates with hyperbilirubinemia is associated with significant reduction of serum bilirubin levels Khafaga et al 2022 The present study is to compare the effects of Fenofibrate adjuvant to phototherapy with conventional phototherapy for exaggerated neonatal hyperbilirubinemia in the form of bilirubin reduction duration of phototherapy hospital stay observation of side-effects
Administration of a single dose of fenofibrate as an adjunct along with phototherapy to neonates showed a significant reduction of serum bilirubin and duration of phototherapy The duration was shorter in the fenofibrate group in comparison to the control group No side effects of fenofibrate were observed after a single dose administration Islam et al 2021 Newborns admitted in neonatal units of pediatric medicine unit I Services Hospital Lahore and fulfilling the inclusion exclusion criteria will be the study subject The patients will be divided randomly into two groups ie group A intervention and group B non-intervention Randomization will be performed by using computer generated numbers
The parentguardian of the neonate will be informed about the study verbally and informed consent will be taken The demographic data will be obtained detailed history regarding symptoms onset of disease duration of illness progression and medication will be taken General physical examination and systemic examination will be carried out
In babies with jaundice clothes will be taken off but eyes and genitalia will be covered Baby will be kept under phototherapy at baby-to-light distance of 20-40 cm Gomella ed 2013 with changing position every 2 hourly to expose as much part as possible Single dose of Fenofibrate will be given to the group A intervention group at dose of 10mgKg Al-Asy et al 2015 Group B non-intervention will only be given phototherapy Then every 24-hourly sample for serum bilirubin will be sent for lab analysis for 3 days Fenofibrate is readily available in market as 200mg 67mg generic capsule which will be diluted with sterile distilled water in syringe dropper calculated amount of dose will be given orally
Outcome of this study will be measured by number of days needed for serum bilirubin to decrease below phototherapy range in both groups If the role of Fenofibrate is established in the management of exaggerated physiological hyperbilirubinemia in newborns it will be beneficial to minimize the risk of the complications off prolong phototherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None