1 - Neonatal Intensive Care Unit, Woman, Infant and Adolescent Department, Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central. Lisbon, Portugal;
2 - Pharmacy Department, Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central. Lisbon, Portugal;
3 - Research Unit, Centro Hospitalar de Lisboa Central. Lisbon, Portugal;
4 - Division Metabolic Diseases and Nutrition, Department of Pediatrics, Children's Hospital, Dr. von Haunersches Kinderspital, Ludwig-Maximilians-University. Munich, Germany.
- Comunicação oral na reunião internacional: 21º Congresso Latino Americano, 12º Congresso Ibero Americano de Gastroenterologia, Hepatologia e Nutrição Pediátrica e XXX Reunião da Sociedade Portuguesa de Gastroenterologia Hepatologia e Nutrição Pediátrica de 22 a 24 de Junho de 2017, no Centro de Congressos da Alfândega do Porto.
Background: Parenteral nutrition-associated cholestasis (PNAC) is a common complication of prolonged exclusive parenteral nutrition (PN). The prevention of PNAC was assessed in term and near-term neonates using two intravenous lipid emulsions (LE) composed of either 30% long-chain triglycerides (LCT) n-6, 30% medium-chain triglycerides (MCT), 25% monounsaturated fatty acids, and 15% LCT n-3 (MOFS group) or 50% MCT and 50% LCT n-6 (MCT/LCT group).
Methods: A single-center, double-blinded, randomized, controlled trial compared the incidence of PNAC using PN with either MOFS or MCT/LCT in neonates born at gestational age ³34 weeks, undergoing major corrective surgery. The incidence of serum markers of PNAC and other PN-associated liver disease markers were considered primary and secondary outcomes. A post-hoc analysis assessed serum triglycerides levels. Odds-ratios were estimated by mixed effects regression models. (ClinicalTrials.gov NCT02633384).
Results: The study was interrupted due to shortage of one of the LE, and a sample of 49 infants (MOFS group 22, MCT/LCT group 27) was included. The exposure to the intervention (time on TPN, time on exclusive TPN, cumulative dose of lipids) was similar in both groups. Similar cumulative incidence rates were found for high serum conjugated bilirubin, GGT, AST, and ALT. Hypertriglyceridemia (12/49) was more frequent in MCT/LCT group 37.0% (95% CI 21.53-55.77) than in MOFS group 9.1% (95% CI 2.53-27.81) (p=0.024). Serum triglyceride levels increased a mean of 36.5 mg/dL in MCT/LCT group compared with MOFS group (p=0.013).
Conclusion: MOFS may not be safer than MCT/LCT in preventing PNAC, but is associated with lower serum triglyceride levels.
Palavras Chave: cholestasis, intravenous lipid emulsion, newborn infant, parenteral nutrition-associated, triglyceridemia