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 - Ludwig-Maximilians-Universität München, Division Metabolic Diseases and Nutrition, Department of Pediatrics, Children's Hospital, Dr. von Haunersches Kinderspital, Div. Metabolic and Nutritional Medicine, Univ. of Munich Medical Center Ludwig-Maximilians-University. Munich, Germany
- XLV Jornadas Nacionais de Neonatologia. Lisboa, 18 Novembro 2016 (Comunicação livre).
Background: Cholestasis is a common complication of prolonged parenteral nutrition (PN) in infancy. We studied the effects of two intravenous lipid emulsions composed of either 30% soybean oil, 30% medium-chain triglycerides (MCT), 25% olive oil, and 15% fish oil (SMOF) or 50% MCT and 50% soybean oil n-6 (MCT/SOY) on the incidence of cholestasis in surgical term and near-term neonates.
Methods: A single-center, double-blinded, randomized controlled trial compared the incidence of cholestasis using either SMOF or MCT/SOY in neonates born at gestational age 34 weeks undergoing major surgery. The primary outcome was the incidence of conjugated serum bilirubin >1 mg/dl. Other liver enzymes were assessed as secondary outcomes. A post-hoc analysis assessed serum triglycerides levels. Odds ratios were estimated by mixed-effects regression models.
Results: Enrolment was prematurely interrupted because the MCT/SOY became unavailable, thus 49 infants (SMOF 22, MCT/SOY 27) completed the study. The exposure (time on PN, cumulative dose of lipids) was similar in both groups. Similar cumulative incidence rates were found for elevated conjugated bilirubinemia and other liver enzymes. Hypertriglyceridemia (12/49) was more frequent in MCT/SOY (37.0%, 95% CI 21.53-55.77) than in SMOF (9.1%, 95% CI 2.53-27.81, p=0.024). Triglyceridemia at the first assessment (median 8 postnatal days) was significantly higher with MCT/SOY than with SMOF (181 vs. 134 mg/dL, p=0.006). Over the whole study period, triglyceridemia was 36.5 mg/dL higher with MCT/SOY compared with SMOF (p=0.013).
Conclusion: Both emulsions had similar effects on the incidence of cholestasis and markers of liver integrity, but MCT/SOY induced higher serum triglyceride concentrations.
Palavras-chave: intravenous lipid emulsion; newborn infant; parenteral nutrition-associated cholestasis; hypertriglyceridemia