Standard Lipid Therapy vs IVFE Minimization for Prevention of PNALD

University of Michigan

Status and phase: Completed; Phase 3

Conditions: Cholestasis

Treatments: Drug: Intralipid 20% I.V. Fat Emulsion

Study type: Interventional

Funder types: Other

Identifiers

NCT02357576

HUM00075458

1R01FD005085-01A1

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Reduced Lipid

Experimental group

Description:

Subjects will receive a minimized dose (1 g/kg/day) of the soybean-based lipid component of parenteral nutrition.

Treatment:

Drug: Intralipid 20% I.V. Fat Emulsion

Standard Lipid

Active Comparator group

Description:

Subjects will receive the standard dose (up to 3 g/kg/day) of the soybean-based lipid component of parenteral nutrition.

Treatment:

Drug: Intralipid 20% I.V. Fat Emulsion