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

Journal of Perinatology volume 41, pages 865–872 (2021)Cite this article

Subjects

Abstract

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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Author information

Authors and Affiliations

  1. Department of pediatrics, Mansoura University Children’s Hospital, Mansoura, Egypt

    Mohammad Hosny Awad, Mona Hafez, Islam Nour & AbdElaziz Shabaan

  2. Department of pediatrics, Insurance Hospital, Ministry of health, Mansoura, Egypt

    Sahar Amer

  3. Department of pediatrics, New Mowasat Hospital, Salmiya, Kuwait

    AbdElaziz Shabaan

Authors
  1. Mohammad Hosny Awad
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  2. Sahar Amer
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  3. Mona Hafez
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  4. Islam Nour
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  5. AbdElaziz Shabaan
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Contributions

MHA shared in the statistical analysis of the study, initial manuscript, and approved the final manuscript. SA shared in study design, recruitment of patients, collection of the data, statistical analysis of the study, and approved the final manuscript. MH shared in the study design, manuscript revision, and approved the final manuscript. IN shared in the study design, collection of data, adjustment of references, manuscript revision, and approved the final manuscript. AS shared in hypothesis formulation, study design, critically reviewed and revised the manuscript, and approved the final manuscript.

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Correspondence to Mohammad Hosny Awad.

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Awad, M.H., Amer, S., Hafez, M. et al. “Fenofibrate as an adjuvant to phototherapy in pathological unconjugated hyperbilirubinemia in neonates: a randomized control trial.”. J Perinatol 41, 865–872 (2021). https://doi.org/10.1038/s41372-020-00861-2

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  • DOI: https://doi.org/10.1038/s41372-020-00861-2

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