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SMOFlipid to Lessen the Severity of Neonatal Cholestasis

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ClinicalTrials.gov Identifier: NCT02721277
Recruitment Status : Terminated
First Posted : March 29, 2016
Results First Posted : April 17, 2017
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
University of Florida

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 chances of both a good neurological outcome and survival.

The aim of this research study is to determine if the unique formulation of SMOFLipid will cause less hepatic inflammation compared to soy only intralipids.


Condition or disease Intervention/treatment Phase
Cholestasis Jaundice, Obstructive Drug: SMOFlipid Phase 1 Phase 2

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : May 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : February 2, 2017


Arm Intervention/treatment
Experimental: SMOFlipid
Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
Drug: SMOFlipid
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.
Other Name: Parenteral nutrition (PN)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Measurement of Head Circumference for Growth Increase [ Time Frame: 6 months ]
    Growth increase will be measured by head circumference of participants.

  2. Measurement of Weight for Growth Increase [ Time Frame: 6 months ]
    Growth increase will be measured by weight of participants.

  3. Measurement of Length for Growth Increase [ Time Frame: 6 months ]
    Growth increase will be measured by length of participants.

  4. Number of Subjects Requiring Surgery [ Time Frame: 6 months ]
  5. Number of Concomitant Medications Received [ Time Frame: 6 months ]
  6. Length of IV Nutritional Therapy [ Time Frame: 6 months ]
  7. Number of Subjects Receiving Formula Diet [ Time Frame: 6 months ]
    Enteral administration of formula will be noted

  8. Number of Subjects Receiving Breast Milk Diet [ Time Frame: 6 months ]
    Enteral administration of breast milk will be noted

  9. Number of Participants With Adverse Events Related to Treatment [ Time Frame: 6 months ]
    Laboratory values will be used to determine adverse events.

  10. Carbon Dioxide Total [ Time Frame: 6 months ]
    Laboratory value that determines acid-base balance

  11. Total Protein [ Time Frame: 6 months ]
    Laboratory value that evaluates liver function

  12. Albumin [ Time Frame: 6 months ]
    Laboratory value that evaluates liver function

  13. Aspartate Aminotransferase [ Time Frame: 6 months ]
    Laboratory value that evaluates liver function

  14. Alanine Aminotransferase [ Time Frame: 6 months ]
    Laboratory value that evaluates liver function

  15. Total Bilirubin [ Time Frame: 6 months ]
    Laboratory value that evaluates liver function

  16. Serum Glucose [ Time Frame: 6 months ]
    Laboratory values that evaluates glucose in the blood

  17. Alkaline Phosphatase [ Time Frame: 6 months ]
    Laboratory value that evaluates liver function

  18. Triglyceride [ Time Frame: 6 months ]
    Laboratory value that evaluates liver function and metabolism of fat


Other Outcome Measures:
  1. Number of Days on Mechanical Ventilation Via Endotracheal Tube [ Time Frame: 6 months ]
    Length of therapy with mechanical ventilation

  2. Number of Days on Oxygen Via Continuous Positive Airway Pressure [ Time Frame: 6 months ]
    Length of therapy with nasal continuous positive airway pressure

  3. Number of Days on Oxygen Via Nasal Cannula [ Time Frame: 6 months ]
    Length of therapy with nasal cannula

  4. Number of Days With Central Venous Catheter [ Time Frame: 6 months ]
  5. Number of Blood Infections [ Time Frame: 6 months ]
    A review of the subject's medical record will determine the presence of bacterial, viral, or fungi colony-forming units (CFU) in the blood.

  6. Numbers of Blood Infection Obtained From a Venipuncture [ Time Frame: 6 months ]
    A review of the subject's medical record will determine the location from which positive blood cultures were obtained.

  7. Numbers of Blood Infection Obtained From a Central Venous Catheter [ Time Frame: 6 months ]
    A review of the subject's medical record will determine the location from which positive blood cultures were obtained.



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Ages Eligible for Study:   23 Weeks to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Greater than 14 days old and less than 1 year of age.
  • Greater than 1 kg.
  • Mild cholestasis, defined as a conjugated bilirubin between 0.5-1.9 mg/dL
  • Currently standard therapy with soy-based Intralipid
  • Evidence of growth of weight, head circumference or length below our standards for post-menstrual age for at least 1 week.
  • Be expected to require intravenous nutrition for at least an additional 21 days

Exclusion Criteria:

  • Have a congenitally lethal condition.
  • Have clinically severe bleeding or clinical liver failure not able to be managed with routine measures.
  • Have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
  • Have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721277


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Josef Neu, MD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02721277     History of Changes
Other Study ID Numbers: IRB201600068
First Posted: March 29, 2016    Key Record Dates
Results First Posted: April 17, 2017
Last Update Posted: April 17, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Parenteral nutrition, Total
Infant, newborn
Cholestasis
Enterocolitis, Necrotizing

Additional relevant MeSH terms:
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Cholestasis
Jaundice
Jaundice, Obstructive
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms