Standard Lipid Therapy vs IVFE Minimization for Prevention of PNALD
Condition: Cholestasis
MeSH terms: Cholestasis
Intervention: Intralipid 20% I.V. Fat Emulsion
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Maximum age: 1 Year
Healthy volunteers: No

Summary:

      Parenteral nutrition-associated cholestasis (PNAC) and liver disease (PNALD) are associated
      with significant morbidity and mortality in neonates and is felt to be exacerbated by
      soybean-based lipid emulsions. Much research is currently being directed at identifying ways
      to reduce this risk. Reduction of the dose of soybean-based lipid given as a component of
      parenteral nutrition is one possible strategy. In this study we will compare standard dosing
      of soybean-based lipid (up to 3/kg/day) with a minimized dose (1 g/kg/day) and evaluate for
      the development of cholestasis and adequate growth between the two groups. Longterm followup
      will include an assessment of neurodevelopmental outcomes at 12 and 24 months of age.

      Funding source - FDA OOPD
    

Eligibility criteria:

        Inclusion Criteria:

          -  neonates and infants who are at least 28 weeks corrected gestational age at the time
             of enrollment who are parenteral nutrition (PN) naive

          -  current direct bilirubin <2 mg/dL

          -  any of the following conditions:

          -  meconium ileus and peritonitis

          -  gastroschisis

          -  omphalocele >4cm or with liver herniated outside of the abdominal cavity

          -  necrotizing enterocolitis requiring surgical intervention

          -  volvulus

          -  intestinal atresia with >50% bowel loss

        Exclusion Criteria:

          -  weight <1 kg

          -  metabolic pathway defect which is associated with liver dysfunction in the neonatal
             period, including: hereditary fructose intolerance, galactosemia due to transferase
             deficiency and neonatal tyrosinemia, and/or disorder of lipid metabolism

          -  hepatic insufficiency as documented by either a biopsy with cirrhosis and/or marked
             aberration in synthetic function

          -  renal failure

          -  primary or secondary liver disease, regardless of liver function (includes hepatitis)

          -  use of extracorporeal membrane oxygenation (ECMO)

          -  suspected congenital obstruction of the hepatobiliary tree

          -  documented active infection which may be communicable, including infections hepatitis
             or HIV

          -  previous receipt of choleretic agents

          -  currently receiving phenobarbital or other barbiturates

          -  history of PNAC

          -  direct bilirubin >=2 mg/dL at time of enrollment

          -  congenital or acquired anomaly which will require major cardiovascular surgery

          -  major congenital or chromosomal anomaly

          -  hypoxic ischemic encephalopathy

          -  congenital defect of the brain

          -  major seizure disorder