Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Incidence and Severity of Parenteral Nutrition Associated Cholestasis in Neonates Subjected to Major Surgery, Using Two Mixed Intravenous Lipid Emulsions
Brief Summary: 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.


Options:
A: Arm Label: Smoflipid; Type: EXPERIMENTAL; Interventions: Drug: SMOFLIPID | Arm Label: Intralipid; Type: ACTIVE_COMPARATOR; Interventions: Drug: INTRALIPID | Intervention Type: DRUG; Name: SMOFLIPID; Assigned to Arm(s): Smoflipid | Intervention Type: DRUG; Name: INTRALIPID; Assigned to Arm(s): Intralipid
B: Arm Label: 1) Intralipid; Type: ACTIVE_COMPARATOR; Interventions: Drug: Intralipid 20% | Arm Label: 2) SMOFlipid; Type: EXPERIMENTAL; Interventions: Drug: SMOFlipid 20% | Intervention Type: DRUG; Name: Intralipid 20%; Assigned to Arm(s): 1) Intralipid | Intervention Type: DRUG; Name: SMOFlipid 20%; Assigned to Arm(s): 2) SMOFlipid
C: Arm Label: SMOFlipid; Type: EXPERIMENTAL; Interventions: Other: SMOFlipid | Arm Label: Lipofundin; Type: OTHER; Interventions: Other: Lipofundin | Intervention Type: OTHER; Name: SMOFlipid; Assigned to Arm(s): SMOFlipid | Intervention Type: OTHER; Name: Lipofundin; Assigned to Arm(s): Lipofundin
D: Arm Label: Olive oil lipid emulsion; Type: EXPERIMENTAL; Interventions: Drug: ClinOleic | Arm Label: MCT/LCT lipid emulsion; Type: EXPERIMENTAL; Interventions: Drug: Lipofundin | Arm Label: LCT lipid emulsion; Type: EXPERIMENTAL; Interventions: Drug: Intralipid | Intervention Type: DRUG; Name: ClinOleic; Assigned to Arm(s): Olive oil lipid emulsion | Intervention Type: DRUG; Name: Lipofundin; Assigned to Arm(s): MCT/LCT lipid emulsion | Intervention Type: DRUG; Name: Intralipid; Assigned to Arm(s): LCT lipid emulsion

Answer: C