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Published on: September 20, 2019
Ursodeoxycholic acid prevention on cholestasis associated with total parenteral nutrition in preterm infants: a
Si-Ying Liu1, Li-Wen Chang1, Jing Wang1
1Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan, 430030, Hubei, China.
Insights
Ursodeoxycholic acid (UDCA) prevents parenteral nutrition-associated cholestasis (PNAC) in preterm infants. This study found UDCA significantly reduced direct bilirubin levels and cholestasis incidence in neonates receiving long-term parenteral nutrition (PN).
Area of Science:
- Neonatology
- Pediatric Gastroenterology
- Clinical Pharmacology
Background:
- Preterm infants on long-term parenteral nutrition (PN) are susceptible to parenteral nutrition-associated cholestasis (PNAC).
- Ursodeoxycholic acid (UDCA) is being investigated for its potential to prevent PNAC.
Purpose of the Study:
- To evaluate the prophylactic efficacy and safety of oral UDCA in preventing PNAC in preterm infants.
- To assess the impact of UDCA on bilirubin levels and cholestasis incidence in neonates requiring PN.
Main Methods:
- A randomized, open-label, proof-of-concept trial was conducted.
- Low-birth-weight preterm infants (<1800g) receiving PN in the NICU were randomized to receive either oral UDCA prophylaxis or no prophylaxis.
- The primary endpoint was the weekly measurement of direct bilirubin (DB) levels.
Main Results:
- A total of 102 preterm neonates were enrolled.
- The UDCA group showed significantly lower peak serum direct bilirubin levels (13.0 vs. 15.2 μmol/L) and total bilirubin levels (101.1 vs. 116.5 μmol/L) compared to the control group.
- The incidence of neonatal cholestasis was significantly lower in the UDCA group (0.0% vs. 11.7%).
Conclusions:
- Oral UDCA prophylaxis is effective in preventing PNAC in preterm infants receiving prolonged PN.
- UDCA administration is associated with reduced bilirubin levels and a lower incidence of cholestasis in this vulnerable population.
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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