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Ursodeoxycholic acid prevention on cholestasis associated with total parenteral nutrition in preterm infants: a randomized trial

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Abstract

Background

Preterm infants with long-term parenteral nutrition (PN) therapy are at risk for cholestasis associated with total parenteral nutrition (PNAC). This study examined the safety and efficacy of ursodeoxycholic acid (UDCA) in preventing PNAC in preterm infants. Our research aimed to investigate the prophylactic effect of preventive oral UDCA on PNAC in preterm infants.

Methods

We compared oral administration of UDCA prophylaxis with no prophylaxis in a randomized, open-label, proof-of-concept trial in preterm neonates with PN therapy. The low-birth-weight preterm infants (< 1800 g) who were registered to the neonatal intensive care unit (NICU) within 24 hours after birth were randomized. The main endpoint was the weekly values of direct bilirubin (DB) of neonates during the NICU stay.

Results

Eventually, a total of 102 preterm neonates from January 2021 to July 2021 were enrolled in this prospective study (42 in the UDCA group and 60 in the control group). Notably, the peak serum level of DB [13.0 (12–16) vs. 15.2 (12.5–19.6) μmol/L, P < 0.05)] was significantly lower in the UDCA group than that in the control group without prevention. The peak serum level of total bilirubin (101.1 ± 34 vs. 116.5 ± 28.7 μmol/L, P < 0.05) was also significantly lower in the UDCA group than in the control group. Furthermore, the proportion of patients who suffered from neonatal cholestasis (0.0% vs. 11.7%, P < 0.05) in the UDCA group was significantly lower.

Conclusion

UDCA prophylaxis is beneficial in preventing PNAC in NICU infants receiving prolonged PN.

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Data availability

The datasets generated and analyzed during this study are available from the corresponding author on reasonable request.

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Funding

The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

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Authors and Affiliations

  1. Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan, 430030, Hubei, China

    Si-Ying Liu, Li-Wen Chang, Jing Wang, Min Xie, Lei-Lei Chen & Wei Liu

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  1. Si-Ying Liu
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  2. Li-Wen Chang
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  3. Jing Wang
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  4. Min Xie
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  5. Lei-Lei Chen
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  6. Wei Liu
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Contributions

SL: conceptualization, data curation, writing—original draft, writing—review and editing, and software. WL: conceptualization, writing—review and editing, and supervision. LC and JW: investigation and project administration. LC and MX: software and supervision and validation. All authors have drafted the article or revised it critically for important intellectual content. All authors have read and agreed to the published version of the manuscript.

Corresponding author

Correspondence to Wei Liu.

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Ethical approval

All procedures performed in studies involving human participants were conducted according to the guidelines of the 1994 Declaration of Helsinki, and approved by the Ethics Committee of Tongji Hospital (TJ-IRB20210828).

Conflict of interest

No financial or non-financial benefits have been received or will be received from any party related directly or indirectly to the subject of this article.

Informed consent

Informed consents have been obtained from all individual participant’s parent or legal guardian included in the study.

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Liu, SY., Chang, LW., Wang, J. et al. Ursodeoxycholic acid prevention on cholestasis associated with total parenteral nutrition in preterm infants: a randomized trial. World J Pediatr 18, 100–108 (2022). https://doi.org/10.1007/s12519-021-00487-0

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  • DOI: https://doi.org/10.1007/s12519-021-00487-0

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