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"Fenofibrate as an adjuvant to phototherapy in pathological unconjugated hyperbilirubinemia in neonates: a randomized
Mohammad Hosny Awad1, Sahar Amer2, Mona Hafez3
1Department of pediatrics, Mansoura University Children's Hospital, Mansoura, Egypt. mo7amed_hosny@hotmail.com.
Insights
Adding fenofibrate to phototherapy significantly reduces bilirubin levels in newborns with jaundice. This treatment shortens phototherapy duration and hospital stays, promoting exclusive breastfeeding without adverse effects.
Area of Science:
- Neonatal Medicine
- Pediatric Gastroenterology
- Pharmacology
Background:
- Pathological jaundice in newborns often requires invasive treatments beyond phototherapy.
- Existing therapies like intravenous immunoglobulin and exchange transfusions carry significant risks.
Purpose of the Study:
- To evaluate the efficacy and safety of fenofibrate as an adjunct to phototherapy for pathological jaundice in full-term infants.
- To determine if fenofibrate can reduce the need for more invasive treatments.
Main Methods:
- A double-blind, randomized controlled study involved 180 full-term infants with pathological unconjugated hyperbilirubinemia.
- Infants received either oral fenofibrate (10 mg/kg/day for 1 or 2 days) or placebo, alongside phototherapy.
- Primary outcome: total serum bilirubin levels at 12, 24, 36, 48, and 72 hours.
Main Results:
- Fenofibrate groups showed a significant reduction in bilirubin levels at 36, 48, and 72 hours compared to the placebo group.
- Fenofibrate administration led to a shorter duration of phototherapy and hospital stay.
- Higher rates of exclusive breastfeeding on discharge were observed in fenofibrate-treated infants.
Conclusions:
- Fenofibrate is well-tolerated as an adjuvant to phototherapy in term neonates with pathological jaundice.
- It significantly reduces serum bilirubin levels, shortens treatment duration, and improves breastfeeding rates.
- No significant adverse effects were noted with single or double dosage regimens.
Background:
Despite widespread phototherapy usage, many new-born infants remain in need of other invasive lines of therapy, such as intravenous immunoglobulins and exchange transfusions.
Objective:
Assessment of the efficacy and the safety of adding fenofibrate to phototherapy for the treatment of pathological jaundice in full-term infants.
Design/Methods:
We conducted a double blinded randomized control study on 180 full-term infants with pathological unconjugated hyperbilirubinemia admitted to the NICU at Mansoura University Children's Hospital. They were randomly assigned to receive either oral fenofibrate 10 mg/kg/day for 1 day or 2 days or placebo in addition to phototherapy. The primary outcome was total serum bilirubin values after 12, 24, 36, 48, and 72 h from intervention. Secondary outcomes were total duration of treatment, need for exchange transfusions and intravenous immunoglobulin, exclusive breast-feeding on discharge, and adverse effects of fenofibrate. This study was registered at www.clinicaltrials.gov (NCT04418180).
Results:
A total of 180 full-term infants were included, 60 in each group. Infants in group I and II showed significant reduction of bilirubin levels at 36, 48, and 72 h from intervention compared to group III, respectively. Fenofibrate administration was associated with significantly shorter duration of phototherapy, shorter hospital stay, and higher frequency of exclusive breast-feeding compared to phototherapy alone.
Conclusion(S):
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.
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