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Terminated
The study was terminated due to slow enrollment.

Low Dose Fat for the Prevention of Liver Disease in Babies With Gastrointestinal Disorders

ClinicalTrials.gov ID NCT01373918
Sponsor University of California, Los Angeles
Information provided by Kara L. Calkins, MD, University of California, Los Angeles (Responsible Party)
Last Update Posted 2016-06-16
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Study Overview

Brief Summary

Neonates with congenital/acquired gastrointestinal disorders are at high risk for Parenteral Nutrition Associated Cholestasis (PNAC). Besides enteral nutrition, standard therapies to prevent and treat PNAC have been limited and marginal. Recently, the dose and composition of standard intravenous fat emulsions have implicated in the development and progression of PNAC.

In this study, neonates with congenital/acquired gastrointestinal disorders will be randomized, in a unblinded fashion, to receive either the standard dose of an intravenous omega-6 fatty acid emulsion or a low dose of an intravenous omega-6 fatty acid emulsion throughout their course of PN or until hospital discharge, death or 100 days of life, whichever comes first. The primary outcome will be the presence of cholestasis.

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Detailed Description

Parenteral Nutrition (PN) acts as an intravenous source of both macronutrients and micronutrients when enteral feeds are not possible. Intravenous fat emulsions often supplement PN and provide a dense source of non-protein calories and essential fatty acids. Although PN is life-sustaining, it is associated with a myriad of life-threatening complications including Parenteral Nutrition Associated Cholestasis (PNAC). Children dependent on PN for an extended period of time are high risk for liver failure.

The etiology of PNAC remains poorly understood. Neonates with congenital and acquired gastrointestinal disorders are at high risk for PNAC and its subsequent complications. Examples of these gastrointestinal disorders include gastroschisis, volvulus, atresias, dysmotility and malabsorption disorders, pseudo-obstruction, and Hirschsprung's disease. These disorders often render the gut non-functional for extended periods of time. As a result, these patients become PN-dependent and develop PNAC.

Specific PN components have been implicated in the pathogenesis of PNAC. More recently, standard intravenous fat emulsions have been labeled as one of the main culprits contributing to PNAC. Standard intravenous fat emulsions are dosed as high as 4 g/kg/d and are derived from soybean and/or safflower oil, which are rich in omega-6 fatty acids and phytosterols and contain a paucity of omega-3 fatty acids. It is unclear if the dose or high omega-6 fatty acid:omega-3 fatty acid ratio and phytosterols is responsible for the development of PNAC.

The primary specific aim of this study is to determine if PNAC is related to the amount of standard intravenous fat emulsion administered to neonates with congenital/acquired gastrointestinal disorders. The investigators hypothesize that the PNAC is unrelated to the dose of intravenous fat emulsions. To test this hypothesis, neonates with congenital/acquired gastrointestinal disorders will be randomized to low dose standard soybean based parenteral fat, 1 g/kg/d, or standard dose soybean parenteral fat, 3 g/kg/d. Secondary outcomes include: mortality rate, length of stay, and anthropometric measurements at 28 days of life and at the end of the hospital stay, which is expected to be an average of 5 weeks.

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Official Title
Low Dose Parenteral Fat for the Prevention of Parenteral Nutrition Associated Cholestasis in Neonates With Congenital/Acquired Gastrointestinal Disorders
Conditions
Cholestasis
Intervention / Treatment
  • Drug: Intralipid
  • Drug: Intralipid
  • Drug: Intralipid
  • Drug: Intralipid
Other Study ID Numbers
  • 10-001714
Study Start
2010-12
Primary Completion (Actual)
2014-07
Study Completion (Actual)
2014-07
Enrollment (Actual)
41
Study Type
Interventional
Phase
Phase 4

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

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Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

Inclusion Criteria:

  • congenital or acquired gastrointestinal disorder
  • age less than 5 days of life

Exclusion Criteria:

  • congenital intrauterine infection know to be associated with liver involvement
  • known structural liver abnormalities
  • known genetic disorders (trisomy 21, 13, and 18)
  • inborn errors of metabolism
  • infants meeting the criteria for terminal illness (ph:6.8>2 hours)
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Ages Eligible for Study
1 Minute to 5 Days (Child )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Primary Purpose : Prevention
Allocation : Randomized
Interventional Model : Parallel Assignment
Masking : None (Open Label)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Experimental: low dose intravenous fat emulsion
Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).
Intervention/Treatment Drug: Intralipid
  • The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first.

  • Other Names:
    • soybean oil
Participant Group/Arm Active Comparator: standard dose intravenous fat emulsion
Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).
Intervention/Treatment Drug: Intralipid
  • The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first.

  • Other Names:
    • soybean oil
Primary Outcome Measures
Outcome Measure Measure Description Time Frame
Presence of CholestasisCholestasis will be defined by a direct bilirubin > 2 mg/dLprior to 100 days of life, hospital discharge, or death whichever comes first
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
Mortality Ratedeathat the end of the hospital stay which is expected to be an average of 5 weeks
Anthropometric MeasurementsGrowth will be assessed by growth velocity at 28 days of age28 days of age
Anthropometric MeasurementsGrowth will be assessed by weight at the time of hospital discharge (approximately 5 weeks)approximately 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
University of California, Los Angeles
Collaborators
  • St. Louis University
Investigators
  • Principal Investigator:Kara L Calkins, MD,University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2011-06-06
First Submitted that Met QC Criteria
2011-06-14
First Posted (Estimated)
2011-06-15
Results Reporting Dates
Results First Submitted
2016-02-22
Results First Submitted that Met QC Criteria
2016-05-10
Results First Posted (Estimated)
2016-06-16
Study Record Updates
Last Update Submitted that met QC Criteria
2016-05-10
Last Update Posted (Estimated)
2016-06-16
Last Verified
2016-05

More Information

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Keywords Provided by Kara L. Calkins, MD, University of California, Los Angeles
Additional Relevant MeSH Terms

Plan to Share Individual Participant Data (IPD)?
No