“Fenofibrate as an adjuvant to phototherapy in pathological unconjugated hyperbilirubinemia in neonates: a randomized control trial.”

Awad, Mohammed; Amer, Sahar; Hafez, Mona; Nour, Islam; Shabaan, AbdElaziz

doi:10.1038/s41372-020-00861-2

Cited by 10 publications

(12 citation statements)

References 23 publications

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“…The results of our study confirms the findings of study of Awad et al (12) who evaluate the efficacy of fenofibrate in treatment of pathological unconjugated neonatal hyperbilirubinemia. The study recruited 90 patients randomly divided into 3 equal groups.…”

Section: Discussionsupporting

confidence: 92%

Fenofibrate As an Adjuvant to Phototherapy in Term Neonates with Hyperbilirubinemia; A Randomized Controlled Clinical Trial

Khafaga¹,

Alsaid²,

Salama³

et al. 2022

The Egyptian Journal of Hospital Medicine

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Background: Neonatal jaundice results from accumulation of bilirubin as fetal hemoglobin is metabolized by the immature liver. It may be physiological or pathological. Although most infants recover without major morbidity, yet some might develop sever hyperbilirubinemia and acute bilirubin encephalopathy as result of high levels of serum bilirubin. Fenofibrate is a member of the fibrates group. It is a safe and inexpensive orally administered fibric acid derivative conventionally used to treat dyslipidemia. In contrast to clofibrate, studies investigating value of fenofibrate in treatment of the conditions are scarce. The aim was to assess Fenofibrate as an adjuvant to phototherapy in Term Neonates with Hyperbilirubinemia; a prospective randomized controlled trial.Patients and Methods: The study recruited 74 patients randomly divided into 2 equal groups. Patients were assigned to receive either phototherapy with single oral dose of fenofibrate suspension (10 mg/kg) on day 1 of phototherapy (Group 1), or phototherapy alone (Group 2). Results: The 2 studied groups were comparable regarding the basic clinical and laboratory data. The whole series comprised 45 (60.8%) males and 29 (39.2%) females. Comparison between total serum bilirubin levels during treatment and on discharge levels showed significant improvement of bilirubin levels in the two studied groups (P-value 0.0001). Comparison between bilirubin levels in the 2 studied groups revealed significantly lower bilirubin levels in fenofibrate treated group when compared with the control group starting at 36 hours after admission till discharge. Conclusion: Fenofibrate as an adjuvant to phototherapy in neonates with hyperbilirubinemia is associated with significant reduction of serum bilirubin levels.

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Section: Discussionsupporting

confidence: 92%

Fenofibrate As an Adjuvant to Phototherapy in Term Neonates with Hyperbilirubinemia; A Randomized Controlled Clinical Trial

Khafaga¹,

Alsaid²,

Salama³

et al. 2022

The Egyptian Journal of Hospital Medicine

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“…Gohil et al reported similar findings [ 18 ]. Interestingly, Awad et al compared fenofibrate for 1 day or 2 days with placebo and showed significant reduction of bilirubin levels at 36, 48, and 72 h from intervention with either fenofibrate groups compared to placebo [ 19 ]; nonetheless, there was no difference between the two fenofibrate groups in this regard, showing that a single dose of fenofibrate is as effective as its double dosing. Another study with findings inconsistent with ours was the case-control study conducted by Gowda et al, who reported comparable decline in bilirubin levels with fenofibrate and phototherapy compared to phototherapy alone [ 20 ]; nevertheless, they used a 5 mg/kg dose of fenofibrate, showing that this dose is not sufficient for the induction of glucuronyl transferase enzyme, a major contributor to bilirubin metabolism.…”

Section: Discussionmentioning

confidence: 99%

“…On the contrary, duration of hospital stay was significantly lower with fenofibrate in Pathak et al’s study [ 17 ]. Awad et al also demonstrated significantly shorter hospital stay with fenofibrate [ 19 ]. This discrepancy can be justified by the difference in the phototherapy protocol, the efficiency of phototherapy devices, and the overall quality of patient care in the two studies.…”

Section: Discussionmentioning

confidence: 99%

“…Furthermore, by reviewing the baseline bilirubin levels of the 3 groups in Awad et al’s study, we found that at least a number of patients had values higher than 20 mg/dL; these patients had been excluded from our study. Moreover, they included both hemolytic and nonhemolytic cases of neonatal jaundice [ 19 ]. Reduction of hospital stay with fenofibrate has also been reported in some other studies [ 10 , 21 – 23 ].…”

Section: Discussionmentioning

confidence: 99%

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Oral fenofibrate for hyperbilirubinemia in term neonates: A single-blind randomized controlled trial

Saadat¹,

Goodarzi²,

Gharaei³

2023

J. Clin. Trans. Sci.

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Background: Hyperbilirubinemia is common in the neonatal period; however, delayed diagnosis or inadequate treatment can cause irreparable damage to the neonates. We aimed to evaluate the efficacy of oral fenofibrate for hyperbilirubinemia in term neonates. Methods: This singleblind randomized controlled trial included 86 term neonates aged 3-7 days, with birth weight ≥2500 g, admitted to Bandar Abbas Children's Hospital, Bandar Abbas Iran, from July 23, 2019, to July 22, 2020. The fenofibrate group received 10 mg/kg oral fenofibrate and phototherapy, while controls only received phototherapy. Serum total bilirubin was measured at 24 and 48 h and at the time of discharge. Hospital length of stay was also noted. Results: The two study groups were comparable regarding age, gender, gestational age, birth weight, and baseline total serum bilirubin levels. Serum total bilirubin levels at 48 h (P < 0.001) and at discharge (P < 0.001) were significantly lower in the fenofibrate group compared to controls. Although hospital length of stay was lower in the fenofibrate group compared to controls, the difference was not statistically significant (P = 0.612). Fenofibrate was more effective on the reduction of serum bilirubin in neonates aged 3-4.5 days starting at the 24 th hour. Moreover, it was more effective in female neonates compared to males starting at the 48 th hour. Conclusions: A single dose of oral fenofibrate reduced total serum bilirubin in term neonates with hyperbilirubinemia without any side effects; however, this effect was more prominent after 48 h.

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“…Ранее применявшиеся консервативные методы лечения желтухи грудного молока (применение фенобарбитала, сернокислой магнезии, L-карнитина) в современные клинические протоколы не включены [4,5]. Ука зывается на опыт однократного или двукратного использования фенофибрата (производное фиброевой кислоты, оказывает гиполипидемический и антиагрегационный эффекты) для усиления эффективности фототерапии при непрямой гипербилирубинемии у доношенных детей [58]. Эффективность и безопасность этого препарата нуждается в дальнейшем изучении.…”

Section: другие консервативные методы лечения желтухи грудного молокаunclassified

Breast Milk Jaundice

Belyaeva,

Bombardirova,

Kurnatovskaya

2024

Vopr. sovr. pediatr.

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The results of modern studies on breast milk jaundice pathogenesis, that is common form of neonatal jaundice, are presented. The major risk factors and diagnostic methods (excluding other forms of jaundice syndrome at recurrent and lingering jaundice in newborns) were defined. The main therapy approaches for breast milk jaundice were presented. Issues of phototherapy indications were discussed. The feasibility of maintaining breastfeeding in case of breast milk jaundice development was proved. This condition requires the attention of pediatricians despite the relatively favorable course and outcomes. The need to continue studies on pathogenetic therapy of such patients was noted.

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“Fenofibrate as an adjuvant to phototherapy in pathological unconjugated hyperbilirubinemia in neonates: a randomized control trial.”

Cited by 10 publications

References 23 publications

Fenofibrate As an Adjuvant to Phototherapy in Term Neonates with Hyperbilirubinemia; A Randomized Controlled Clinical Trial

Fenofibrate As an Adjuvant to Phototherapy in Term Neonates with Hyperbilirubinemia; A Randomized Controlled Clinical Trial

Oral fenofibrate for hyperbilirubinemia in term neonates: A single-blind randomized controlled trial

Breast Milk Jaundice

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