1- Neonatal Intensive Care Unit, Woman, Infant and Adolescent Area, Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central, Lisbon, Portugal
2- Pharmacy Unit, Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central, Lisbon, Portugal
3- Research Unit, Centro Hospitalar de Lisboa Central, Lisbon, Portugal
4- Ludwig-Maximilians-Universit€at München, Division Metabolic Diseases and Nutrition, Department of Pediatrics, Dr. von Hauner Children's Hospital, Univ. of Munich Medical Center, Munich, Germany
- Clinical Nutrition ESPEN 2017;22:7-12
- 21º Congresso Latino Americano e 12º Congresso Ibero Americano de Gastroenterologia, Hepatologia e Nutrição Pediátrica e XXX Reunião da Sociedade Portuguesa de Gastroenterologia Hepatologia e Nutrição Pediátrica, Porto, 2017 (comunicação oral)
Background: Cholestasis is a common complication in infants receiving prolonged parenteral nutrition (PN). We studied the effects of two intravenous lipid emulsions composed with either 30% soybean oil, 30% medium-chain triglycerides (MCT), 25% olive oil, and 15% fish oil (SMOF) or with 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: Enrollment 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 >250 mg/dL (12/49) was more frequent in MCT/SOY (37.0%, 95% CI 21.53e55.77) than in SMOF (9.1%, 95% CI 2.53e27.81, p ¼ 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 ¼ 0.006). Over the whole study period, mean triglyceride concentration was 36.5 mg/dL higher with MCT/SOY compared with SMOF (p ¼ 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.
Trial registration: ClinicalTrials.gov, NCT02633384
Palavras Chave: Hypertriglyceridemia; Intravenous lipid emulsion; Newborn infant; Parenteral nutrition-associated cholestasis;