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Trial record 65 of 180 for:    Phospholipids

Standard Lipid Therapy vs IVFE Minimization for Prevention of PNALD

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ClinicalTrials.gov Identifier: NCT02357576
Recruitment Status : Terminated (insufficient funding)
First Posted : February 6, 2015
Last Update Posted : August 21, 2019
Sponsor:
Collaborators:
Seattle Children's Hospital
University of Florida
Primary Children's Hospital
University of Colorado, Denver
Information provided by (Responsible Party):
Meghan A. Arnold, MD, University of Michigan

Brief 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


Condition or disease Intervention/treatment Phase
Cholestasis Drug: Intralipid 20% I.V. Fat Emulsion Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase 3 Study of Standard Lipid Therapy Versus Intravenous Fat Emulsion Minimization for the Prevention of Parenteral Nutrition-Associated Liver Disease
Actual Study Start Date : May 21, 2016
Actual Primary Completion Date : October 12, 2017
Actual Study Completion Date : October 12, 2017

Arm Intervention/treatment
Experimental: Reduced Lipid
Subjects will receive a minimized dose (1 g/kg/day) of the soybean-based lipid component of parenteral nutrition.
Drug: Intralipid 20% I.V. Fat Emulsion
Active Comparator: Standard Lipid
Subjects will receive the standard dose (up to 3 g/kg/day) of the soybean-based lipid component of parenteral nutrition.
Drug: Intralipid 20% I.V. Fat Emulsion



Primary Outcome Measures :
  1. Rate of rise of direct bilirubin as a function of time [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Incidence of PNAC (direct bilirubin ≥2 mg/dL) [ Time Frame: 12 weeks ]
    The number of occurrences will be compared between the standard and reduced lipid groups.

  2. Incidence of severe PNAC (direct bilirubin ≥4 mg/dL in subjects on parenteral nutrition for at least 2 weeks) [ Time Frame: 12 weeks ]
    The number of occurrences will be compared between the standard and reduced lipid groups.

  3. The time to development of PNAC [ Time Frame: 12 weeks ]
    The time to development will be compared between the standard and reduced lipid groups.

  4. The time to development of severe PNAC [ Time Frame: 12 weeks ]
    The time to development will be compared between the standard and reduced lipid groups.

  5. Peak total bilirubin level [ Time Frame: 12 weeks ]
    This will be compared between the standard and reduced lipid groups.

  6. Peak direct bilirubin level [ Time Frame: 12 weeks ]
    This will be compared between the standard and reduced lipid groups.

  7. The incidence of essential fatty acid deficiency (EFAD) [ Time Frame: 12 weeks ]
    The number of occurrences will be compared between the standard and reduced lipid groups.

  8. Adequacy of growth as evaluated by z-scores for weight [ Time Frame: 12 weeks ]
    The z-scores for this measure will be compared between the two treatment groups using a linear mixed model.

  9. Adequacy of growth as evaluated by z-scores for height [ Time Frame: 12 weeks ]
    The z-scores for this measure will be compared between the two treatment groups using a linear mixed model.

  10. Adequacy of growth as evaluated by z-scores for head circumference [ Time Frame: 12 weeks ]
    The z-scores for this measure will be compared between the two treatment groups using a linear mixed model.

  11. Adverse events, as defined by any episode of sepsis and catheter-related blood stream infections [ Time Frame: 12 weeks ]
    The number of occurrences will be compared between the standard and reduced lipid groups.

  12. Bayley Scales for Infant and Toddler Development (BSID-III) at one year [ Time Frame: 1 year ]
    Raw scores are converted to composite and subscale scores using age-standardized norms. Scale composite average internal consistency reliability coefficients range from .91 to .93 with subtest reliability ranging from .86 to .91.

  13. Bayley Scales for Infant and Toddler Development (BSID-III) at two years [ Time Frame: 2 years ]
    Raw scores are converted to composite and subscale scores using age-standardized norms. Scale composite average internal consistency reliability coefficients range from .91 to .93 with subtest reliability ranging from .86 to .91.

  14. MacArthur-Bates Communicative Development Inventories (CDI) [ Time Frame: 2 years ]
    Scores are reported as percentiles compared to age-standardized norms.

  15. Brief Infant Toddler Social Emotional Assessment (BITSEA) [ Time Frame: 2 years ]
    Dichotomous scores are generated based on cut-off scores, which identify subjects to be at risk. Internal consistency coefficients range from.80 to.82. Test-retest reliability is acceptable at .80-.85. Recent evidence identifies the BITSEA as the best short tool for early detection of psychosocial problems in two-year olds.

  16. Gross Motor Function Classification System (GMFCS) [ Time Frame: 2 years ]
    This classification is based on observation with a scale of 1-5

  17. Behavioral Assessment System for Children-Second Edition (BASC2) [ Time Frame: 2 years ]
    Primary measurements from the BASC-2 including the Adaptive Behavior Composite and the Behavior Symptoms Index will be reported as T-scores and as percentiles. Secondary analyses will be conducted on the subscales.



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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02357576


Locations
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United States, Colorado
University of Colorado/Children's Hospital Colorado
Aurora, Colorado, United States, 80045
United States, Florida
University of Florida
Gainesville, Florida, United States, 32601
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Utah
Primary Children's Hospital
Salt Lake City, Utah, United States, 84132
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
University of Michigan
Seattle Children's Hospital
University of Florida
Primary Children's Hospital
University of Colorado, Denver
Investigators
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Principal Investigator: Meghan A Arnold, MD University of Michigan

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Responsible Party: Meghan A. Arnold, MD, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02357576     History of Changes
Other Study ID Numbers: HUM00075458
1R01FD005085-01A1 ( U.S. FDA Grant/Contract )
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019

Additional relevant MeSH terms:
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Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions