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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.)
Information provided by (Responsible Party):
Camilia Martin, Beth Israel Deaconess Medical Center Identifier:
First received: January 18, 2006
Last updated: March 13, 2017
Last verified: March 2017
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
Drug: Liposyn III 20% (lipid infusion)
Drug: Intralipid 20% (lipid infusion)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (masked role unspecified)
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 Camilia Martin, 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


Ages Eligible for Study:   up to 10 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00278928

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

Responsible Party: Camilia Martin, Associate Professor of Pediatrics, Beth Israel Deaconess Medical Center Identifier: NCT00278928     History of Changes
Other Study ID Numbers: 2005P000275
Study First Received: January 18, 2006
Last Updated: March 13, 2017

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

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions processed this record on May 25, 2017