Primary Outcome Measures:
- Presence vs. absence of PN-associated cholestasis (PNAC) [ Time Frame: 6 months ]
The definition of "Presence vs. Absence of PNAC" will vary with the post conceptual age of the child. In infants > 40 weeks post conceptual age, we will define PN-associated cholestasis as four consecutive measurements (> 6 days apart) of serum direct bilirubin > 2.0mg/dL obtained over a 30 day period in the absence of other demonstrable etiologies of cholestasis. Due to hepatic immaturity, for infants < 40 weeks post conceptual age, PN associated cholestasis will be defined as four consecutive measurements (> 6 days apart) of serum direct bilirubin > 2.0mg/dL obtained over a 42 day period.
Secondary Outcome Measures:
- Fatty acid profiles [ Time Frame: 6 months ]
(i.e., Mead acid levels, triene:tetraene ratios, total omega-3 and omega-6 fatty acid levels, arachidonic acid levels)
- Weight and height gain [ Time Frame: 6 months ]
- Liver function tests [ Time Frame: 6 months ]
(i.e. serum triglycerides, cholesterol, ALT, AST and total and direct bilirubin levels)
- Death from PNALD liver or liver/gastrointestinal tract transplant. [ Time Frame: 1 year ]
- Duration of parenteral nutrition [ Time Frame: 6 months ]
(i.e. enteral feeding tolerance, including days to reach full enteral feeding (approximately 100-125kcal/kg/d + 10%) after randomization and the number of episodes of feeding intolerance (defined as an interruption of enteral feedings for > 12 hrs) , number of infants requiring TPN providing > 10% of total daily fluid volume at 12 weeks after randomization, and duration of TPN providing > 10% of total daily fluid intake)
- Frequency of blood stream infections [ Time Frame: 6 months ]
- Inflammatory markers (C-reactive protein), cytokine levels [ Time Frame: 6 months ]
- Incidence and severity of ROP [ Time Frame: 6 months ]
- Neurodevelopment Assessments [ Time Frame: 6, 12, & 24 months (corrected for gestational age) ]
Neurodevelopment will be assessed at 6, 12, and 24 months (corrected) using Bayley Scales of Infant Development III(mean total, cognitive, language, and motor scaled score; and frequency of each score <70). The MSD parent questionnaire will be mailed at 12 and 24 months (corrected); and the Parent Report of Children's Abilities - Revised (PARCA-R) parent questionnaire will be mailed at 24 months (coorected).
We propose to conduct a randomized controlled clinical trial to determine whether the use of an omega-3 fatty acid based IFE in infants with surgical gastrointestinal disease will improve clinical outcomes compared to infants treated with standard IFE up to 6 months post randomization. Neonates and infants < 3 months old (postnatally) with surgical gastrointestinal disease (defined as congenital or acquired gastrointestinal disease requiring PN for more than 21 days) will be eligible for enrollment. Patients who meet all inclusion and exclusion criteria will be randomized to receive PN with either Intralipid® or Omegaven®. The appearance of both IFEs is indistinguishable, so patients, families and the medical care team will be blinded to treatment group allocation. Aside from the IFE type, the clinical care of both groups of infants will remain unchanged, including standard use of feeding advancement protocols, and treatment of underlying gastrointestinal and other diseases.