Clinical Trial: SMOFlipid to Lessen the Severity of Neonatal Cholestasis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Compassionate Use of an Intravenous Fat Emulsion Comprised of Soy Oil, Medium Chain Triglycerides, Olive Oil, and Fish Oil for Neonates With Parenteral Nutrition Induced Liver Injury

Brief Summary:

Parenteral nutrition (PN) provides intravenous nutritional supplementation for infants unable to absorb adequate enteral nutrients secondary to insufficient intestinal length or function. In early PN-associated cholestasis, the dose of traditional soy based lipid is limited to 1 g/kg/day which often limits the growth capacity of parenteral nutrition-dependent infants. Inadequate growth is directly related to poor neurological outcomes, failure to facilitate mechanical ventilation, and less growth of the neonate's already damaged intestine. Ultimately, these outcomes can lead to severe disability and death. To mitigate these deleterious effects and optimize growth, parenteral nutrition-dependent infants with cholestasis who are not adequately growing on 1 g/kg/day of soy-based lipid emulsion must have a greater intake of lipids to meet their needs for weight, length, and head circumference growth.

SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids. The utility of Omegaven and soy-based lipid emulsion is limited as these are restricted to 1 g/kg/day in cholestatic infants. SMOFlipid is safe to be provided at the usual goal infusion amount of 3 g/kg/day. Because this product includes both omega-6 and omega-3 lipids, it provides the benefits of the omega-3s for the liver and provides more than enough omega-6s to meet essential fatty acid requirements. Its use in situations in which growth is inadequate in babies who must be restricted to 1 g/kg/day can be expected to improve their growth and likely markedly increase their chanc

Detailed Summary:

The neonates who are being treated at the University of Florida Health Neonates Intensive Care Unit and are anticipated to need more than 21 days of intravenous nutrition will be considered as potential subjects. These subjects will receive the unique formulation of SMOFLipid

The following data will be collected from the subject's EMR by members of the research team:

  • Lab values that evaluate liver function
  • Growth parameters like head circumference, length, weight
  • Medical/surgical history
  • Time to resolution of bilirubin, time to liver transplant, time to death
  • Length of hospital stay
  • Rates of blood infections

Subjects will remain on SMOFlipid until weaned from PN.


Sponsor: University of Florida

Current Primary Outcome: Inflammation of the Liver Between the Groups [ Time Frame: 6 months ]

Inflammation of the liver will be evaluated by comparing direct bilirubin values between the two groups.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Measurement of Head Circumference for Growth Increase [ Time Frame: 6 months ]
    Growth increase will be measured by head circumference of participants.
  • Measurement of Weight for Growth Increase [ Time Frame: 6 months ]
    Growth increase will be measured by weight of participants.
  • Measurement of Length for Growth Increase [ Time Frame: 6 months ]
    Growth increase will be measured by length of participants.
  • Number of Subjects Requiring Surgery [ Time Frame: 6 months ]
  • Number of Concomitant Medications Received [ Time Frame: 6 months ]
  • Length of IV Nutritional Therapy [ Time Frame: 6 months ]
  • Number of Subjects Receiving Formula Diet [ Time Frame: 6 months ]
    Enteral administration of formula will be noted
  • Number of Subjects Receiving Breast Milk Diet [ Time Frame: 6 months ]
    Enteral administration of breast milk will be noted
  • Number of Participants With Adverse Events Related to Treatment [ Time Frame: 6 months ]
    Laboratory values will be used to determine adverse events.
  • Carbon Dioxide Total [ Time Frame: 6 months ]
    Laboratory value that determines acid-base balance
  • Total Protein [ Time Frame: 6 months ]
    Laboratory value that evaluates liver function
  • Albumin [ Time Frame: 6 months ]
    Laboratory value that evaluates liver function
  • Aspartate Aminotransferase [ Time Frame: 6 months ]
    Laboratory value that evaluates liver function
  • Alanine Aminotransferase [ Time Frame: 6 months ]
    Laboratory value that evaluates liver function
  • Total Bilirubin [ Time Frame: 6 months ]
    Laboratory value that evaluates liver function
  • Serum Glucose [ Time Frame: 6 months ]
    Laboratory values that evaluates glucose in the blood
  • Alkaline Phosphatase [ Time Frame: 6 months ]
    Laboratory value that evaluates liver function
  • Triglyceride [ Time Frame: 6 months ]
    Laboratory value that evaluates liver function and metabolism of fat


Original Secondary Outcome: Same as current

Information By: University of Florida

Dates:
Date Received: February 23, 2016
Date Started: May 2016
Date Completion:
Last Updated: March 3, 2017
Last Verified: March 2017