Effect of fish oil-based lipid emulsion on prevention of parenteral nutrition-associated cholestasis in gastrointestinal surgical infants

Not Applicable

Conditions: Diseases of the digestive system

Registration Number: KCT0006184

Lead Sponsor: Samsung Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

1. Infants under 3 months of age who have undergone gastrointestinal surgery*
2.Direct bilirubin less than 1.0 mg/dL
3. Expect to use PN for more than 2 weeks in the future
4. The ratio of calories supplied by oral nutrition to the total calories is less than 60%
5. 1,000 g or more in weight
6. At least 25 weeks gestational age at birth

*Gastrointestinal surgery: necrotizing enterocolitis (NEC), spontaneous intestinal perforation, intestinal atresia, gastrointestinal motility disorder, congenital abdominal hernia/abdominal wall rupture (omphalocele/gastroschisis), intestinal malroation, meconium peritonitis, and other causes such as necrosis of the small and large intestine. .

Exclusion Criteria

1.Basic diseases: Patients diagnosed with congenital diseases that can cause biliary stasis (congenital or acquired TORCH syndrome, syphilis, HIV, hepatitis B or C, metabolic or primary liver diseases, biliary atresia, intra- or extrahepatic diseases obstructing bile flow) )
2. Patients with neonatal sepsis or hemodynamically unstable condition requiring the use of a booster
3. Patients with severe blood clotting disorder (platelet count less than 150,000/mm3, INR 2.0 or more)
4. Patients taking anticoagulants
5. Patients with dyslipidemia or severe hyperlipidemia
6. Patients with severe liver failure or kidney failure
7. Patients with contraindications to jugular vein nutrition
8. Patients with hypersensitivity to fish, eggs, soybeans, peanut protein, or the active ingredients or additives of this drug
9. Patients with signs or symptoms of anaphylactic reaction (fever, tremor, rash, shortness of breath, etc.)
10. General contraindications of fluid therapy: patients with acute pulmonary edema, patients with excessive fluid supply, patients with target dysfunction, heart failure
11. Patients participating in other clinical studies