Reduction of Neonatal Parenteral Nutrition Associated Cholestasis Through Lipid Emulsions
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|ClinicalTrials.gov Identifier: NCT02633384|
Recruitment Status : Terminated (One of the intravenous lipid emulsions was retired from the market)
First Posted : December 17, 2015
Last Update Posted : July 13, 2017
Parenteral nutrition associated cholestasis (PNAC) is a common complication of prolonged and exclusive parenteral nutrition (PN). Infants subjected to major surgery are often unable to receive enteral nutrition for a long period of time, during which they require exclusive PN. In preterm infants, hepatic immaturity is a predisposing factor. Intravenous lipid emulsions (ILE) used in PN may promote PNAC or protect against it depending on their composition. Medium chain triglycerides (MCT) may have a hepatic protective effect. Long chain triglycerides (LCT) of n-3 family may protect from PNAC. In several new-generation emulsions, the α-tocopherol content is higher than the gamma-tocopherol content, acting as an antioxidant, preventing lipid peroxidation.
The incidence and severity of PNAC in term and near-term infants subjected to corrective surgery for congenital abnormalities and needing prolonged PN using the ILE SMOFlipid® or Lipofundin® is compared. The investigators hypothesise that SMOFlipid® is more protective from PNAC than Lipofundin®.
Single-center, randomized, controlled and double-blinded trial on consecutive neonates admitted in the NICU, with gestational age of 34 weeks or over, undergoing corrective surgery of congenital anomaly of the digestive tract or indirectly affecting the digestive tract. Recruitment if PN with ILE was started within the first 48 hours after birth. Minimum intervention: exclusive PN for at least 1 week.
Main outcome: incidence of cholestasis (conjugated serum bilirubin >1 mg/dl [34 mmol/L]). Severity of cholestasis evaluated by the magnitude of the serum conjugated bilirubin and serum γ-glutamyltranspeptidase (GGT). Mixed effects regression models are used to take into account the correlation structure between measures in time. Crude and adjusted odds-ratios with corresponding 95% confidence intervals are calculated.
|Condition or disease||Intervention/treatment||Phase|
|Intrahepatic, Cholestasis||Other: SMOFlipid Other: Lipofundin||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Incidence and Severity of Parenteral Nutrition Associated Cholestasis in Neonates Subjected to Major Surgery, Using Two Mixed Intravenous Lipid Emulsions|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||April 2017|
infants subjected to corrective surgery for congenital abnormalities and needing prolonged PN using a new generation intravenous lipid emulsion
Exclusive total parenteral nutrition using a new generation intravenous lipid emulsion composed of 30% LCT n-6 (soybean oil), 30% MCT (coconut oil), 25% monounsaturated fatty acids (olive oil), 15% LCT n-3 (fish oil) and α-tocopherol
Other Name: SMOFlipid® (Fresenius Kabi)
infants subjected to corrective surgery for congenital abnormalities and needing prolonged PN using a current intravenous lipid emulsion
Exclusive total parenteral nutrition using a current intravenous lipid emulsion composed of 50% LCT (soybean oil) and 50% MCT (coconut oil)
Other Name: Lipofundin® (B Braun)
- Incidence of cholestasis [ Time Frame: From recruitment to full enteral feeding per mouth (up to 90 postnatal days) ]Conjugated serum bilirubin >1 mg/dl (34 mmol/L) (Moyer, 2004).
- Severity of cholestasis [ Time Frame: From recruitment to full enteral feeding per mouth (up to 90 postnatal days) ]The severity of cholestasis was evaluated by the magnitude of the serum conjugated bilirubin and serum γ-glutamyltranspeptidase (GGT).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633384
|Principal Investigator:||Luis Pereira-da-Silva, MD, PhD||Neonatal Intensive Care Unit, Hospital Dona Estefania, Centro Hospitalar de Lisboa Central|