Prevention of Parenteral Nutrition-associated Cholestasis Using Reduced Dose Soybean Lipid Emulsion: A Multicenter Randomized Trial.

Autor: Maselli KM; Section of Pediatric Surgery, University of Michigan, Ann Arbor, MI 48109, USA., Carter IC; Section of Pediatric Surgery, University of Michigan, Ann Arbor, MI 48109, USA., Matusko N; Section of Pediatric Surgery, University of Michigan, Ann Arbor, MI 48109, USA., Warschausky S; Department of Physical Medicine and Rehabilitation, Ann Arbor, MI 48109, USA., Blackmer AB; Department of Clinical Pharmacology, University of Colorado, Aurora, CO 80045, USA., Islam S; Division of Pediatric Surgery, University of Florida, Gainesville, FL 32610, USA., Rollins MD; Divsion of Pediatric Surgery, University of Utah, Salt Lake City, UT 84113, USA., Javid PJ; Division of Pediatric General and Thoracic Surgery, Seattle Children's Hospital, Seattle, WA 98105, USA., Arnold MA; Section of Pediatric Surgery, University of Michigan, Ann Arbor, MI 48109, USA. Electronic address: meghanar@med.umich.edu.
Jazyk: angličtina
Zdroj: Journal of pediatric surgery [J Pediatr Surg] 2024 Jul; Vol. 59 (7), pp. 1369-1373. Date of Electronic Publication: 2024 Mar 17.
DOI: 10.1016/j.jpedsurg.2024.03.030
Abstrakt: Introduction: Reducing soybean lipid emulsion (SLE) dose may prevent parenteral nutrition-associated cholestasis (PNAC) but effects on growth and neurodevelopment are unknown. The purpose of this study was to evaluate the effect of reduced dose SLE on growth and neurodevelopment.
Methods: Surgical neonates at 4 centers were randomized to standard SLE (3 g/kg/day) or reduced SLE (1 g/kg/day) over a 12-week period. Bilirubin levels and growth parameters were measured baseline and weekly while on study. The effects of time and group on direct bilirubin and growth were evaluated with a linear mixed effects model. Neurodevelopmental outcomes were assessed at 12- and 24-months corrected gestational age.
Results: Twenty-one individuals were randomized (standard dose = 9, reduced dose = 12). Subjects in the reduced dose group had slower rates of direct bilirubin increase and overall levels decreased earlier than those in the standard dose group. There was a trend toward a faster direct bilirubin decrease in the reduced dose group (p = 0.07 at day 84). There were no differences in the rates of change in weight (p = 0.352 at day 84) or height Z-scores (p = 0.11 at day 84) between groups. One subject in the reduced dose group had abnormal neurodevelopmental testing at 24 months.
Conclusions: Surgical neonates randomized to a reduced dose of SLE had improved trends in direct bilirubin levels without clinically significant differences in overall growth and neurodevelopment.
Type of Study: Randomized Controlled Trial.
Level of Evidence: II.
Competing Interests: Conflicts of interest The authors have no competing financial interests to disclose.
(Copyright © 2024. Published by Elsevier Inc.)
Databáze: MEDLINE
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