Cholestasis Prevention: Efficacy of IV Fish Oil

This is an interventional prevention trial for Cholestasis focused on measuring PN, cholestasis, gastrointestinal disease in infants, short bowel syndrome Read More

Inclusion criteria (all of the following):

1. Congenital or acquired gastrointestinal disease requiring surgical intervention [such as Midgut volvulus, Gastroschisis-(with known or suspected atresia(s), perforation(s) requiring a jejunostomy, or bowel resections > 20cm), Omphalocele, Jejunal atresia or NEC-(no peritoneal drains) or duodenal atresia] ; and
2. Expected dependence on parenteral nutrition for full or partial nutritional support for an anticipated duration of therapy of at least 21 days; Subjects will be judged by their clinical team to require PN support a minimum of 21 days based on the following criteria: inability to tolerate enteral feedings, lack of audible bowel sounds, contraindications to initiation of enteral feedings (e.g., grossly bloody stools or other sign of intestinal ischemia, hypotension, bilious emesis, or clinical or radiographic evidence of bowel obstruction); and
3. Neonates and infants < 3 months of age (postnatally); and
4. Gestational age > 28 weeks; and
5. Baseline direct bilirubin less than 1.0 mg/dL (normal); and
6. Weight > 1 kg

Exclusion criteria(any one of the following):

1. Exposure to soybean oil fat emulsion for greater than three weeks (>21 days) at time of enrollment
2. Known or suspected intolerance or allergy to any of the components of the study IFE, including fish, soy or egg protein
3. Inability to obtain written informed consent prior to the baseline labs
4. The patient is enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
5. Intention to transfer care to another patient facility within 3 months of baseline labs
6. Any serum triglyceride level greater than 400 mg/dL at baseline
7. History of severe hemolytic disorders or INR greater than 1.5 at baseline (INR cutoff of greater than 2 for babies less than 1 week of age)
8. History of shock requiring vasopressors (dopamine equal or less than 20 micrograms/kilogram/minute is allowed; all other use of vasopressors is excluded)
9. Preexisting liver disease, regardless of etiology
10. Hemodynamically unstable as judged by PI
11. Renal failure (creatinine greater than 0.4 mg/dL unless less than 1 month of age-then at the PI's discretion)
12. Patient previously had STEP (Serial Transverse Enteroplasty Procedure)
13. Patient is currently on ECMO or nitric oxide
14. GGTP > 80 mg/L at baseline
15. Weight < 1 kg at time of enrollment
16. Gestational age < 28 weeks at time of enrollment