Fat Tolerance From Lipid Emulsion Infusion Packaged in Glass or Plastic

This study has been terminated.
(Manufacturing change in one of the two lipid emulsion products being studied.)
Sponsor:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00278928
First received: January 18, 2006
Last updated: May 16, 2007
Last verified: May 2007
  Purpose

This will be a prospective, randomized trial to determine if differences exist in the tolerance of lipid injectable emulsions in the neonatal intensive care unit (NICU). Lipid injectable emulsions are an essential nutrient for neonatal growth and development. Traditionally, lipid injectable emulsions have been commercially available in sterile glass bottles, but in April of 2004, a new container was introduced as a sterile plastic bag. In January, 2005, NICU personnel observed what appeared to be a higher than usual incidence of hypertriglyceridemia. Upon further laboratory investigation of the lipid injectable emulsions stored in glass bottles versus those in plastic, significant differences were noted in the population of large-diameter fat globules by globule size analysis, reflective of a less stable emulsion in plastic. The United States Pharmacopeia (USP) which sets the standards for drug purity and safety in the U.S., and whose drug monographs are enforceable by the FDA, has proposed to limit this large diameter fat globule population to a volume-weighted percent fat greater than five micrometers or PFAT5 to be less than 0.05% of the total lipid concentration. (At the present time, the USP monograph is not officially recognized, but is on track for adoption in 2006.) Our preliminary analyses of four lots of 20% lipid injectable emulsion packaged in glass to have a PFAT5 of 0.003±0.0008%, compared to an approximate 55-fold increase in the large-diameter fat globule population or 0.166±0.016% for an equal number of products packaged in plastic. We hypothesize this difference may explain the recent clinical observations. We will compare the incidence of hypertriglyceridemia in neonates between lipids packaged in glass versus those in plastic. The study will attempt to discern whether the differences in packaging influence the stability and subsequent tolerance of lipid injectable emulsions.


Condition Intervention
Hypertriglyceridemia
Drug: Liposyn III 20% (lipid infusion)
Drug: Intralipid 20% (lipid infusion)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Prospective, Randomized Study of Fat Tolerance From Lipid Emulsion Infusion Packaged in Glass or Plastic Containers.

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Serum triglyceride level

Secondary Outcome Measures:
  • Total lipid infusion dose at 7 days of life (gms/kg/day)

Estimated Enrollment: 82
Study Start Date: January 2006
Study Completion Date: April 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 10 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients who present to the neonatal intensive care unit at BIDMC who require intravenous nutritional support

Exclusion Criteria:

  • Any patients receiving intravenous steroids
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00278928

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: David F Driscoll, PhD Beth Israel Deaconess Medical Center
Principal Investigator: Camilia R Martin, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00278928     History of Changes
Other Study ID Numbers: 2005-P-000275
Study First Received: January 18, 2006
Last Updated: May 16, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
Hypertriglyceridemia
Infant, Premature

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 22, 2014