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Trial record 92 of 179 for:    Phospholipids

Fat Tolerance From Lipid Emulsion Infusion Packaged in Glass or Plastic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00278928
Recruitment Status : Terminated (Manufacturing change in one of the two lipid emulsion products being studied.)
First Posted : January 19, 2006
Last Update Posted : March 14, 2017
Information provided by (Responsible Party):
Camilia Martin, Beth Israel Deaconess Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Hypertriglyceridemia Drug: Liposyn III 20% (lipid infusion) Drug: Intralipid 20% (lipid infusion) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Prospective, Randomized Study of Fat Tolerance From Lipid Emulsion Infusion Packaged in Glass or Plastic Containers.
Study Start Date : January 2006
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Serum triglyceride level

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

Information from the National Library of Medicine

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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

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 identifier (NCT number): NCT00278928

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

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Responsible Party: Camilia Martin, Associate Professor of Pediatrics, Beth Israel Deaconess Medical Center Identifier: NCT00278928     History of Changes
Other Study ID Numbers: 2005P000275
First Posted: January 19, 2006    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017

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

Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions