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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006184

Enrollment

Registered

2021-05-26

Start date

2022-09-12

Completion date

Unknown

Last updated

2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : The test drug, Fish oil-based lipid emulsion, F-LE (Omegaven

Fresenius Kabi, Bad Homburg, Germany) is a fat emulsion containing only fish oil. The control drug Combination lipid emulsion, SMOF-LE (SMOFlipid

Fresenius Kabi, Bad Homburg, Germany) is a mixed fat emulsion consisting of soybean oil, MCT, olive oil, and fish oil. Currently, infants in the neonatal intensive care unit of our hospital usually us

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Occurrence of PNALD	—

Secondary

Measure	Time frame
Occurrence of coagulopathy;Occurrence of essential fatty acid deficiency;Growth impairment;Mortality;Occurrence of neonatal morbidity	—

Countries

Korea, Republic of

Contacts

Public ContactSanghoon Lee

Samsung Medical Center

4hooni@gmail.com+82-2-3410-3479

Outcome results