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Low Dose Parenteral Fat for Prevention of Parenteral Nutrition Associated Cholestasis in Preterm Neonates

This study has been completed.
Sponsor:
Collaborators:
University of California, Los Angeles
Feinberg School of Medicine, Northwestern University
Information provided by (Responsible Party):
Richard Ehrenkranz, Yale University
ClinicalTrials.gov Identifier:
NCT01050660
First received: December 23, 2009
Last updated: October 27, 2014
Last verified: October 2014
  Purpose

The goal of the study is to determine if parenteral nutrition-associated cholestasis (PNAC) is related to the amount of parenteral (intravenous) fat administered to premature babies until full enteral nutrition is achieved.


Condition Intervention
Parenteral Nutrition-Associated Liver Disease
Other: Intravenous fat emulsion
Other: Restriction of intravenous fat emulsion to 1 gm/kg/d

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Low Dose Parenteral Fat for Prevention of Parenteral Nutrition Associated Cholestasis in Preterm Neonates

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • The Presence of Cholestasis at Age of 28 Days or When Full Enteral Nutrition is Achieved, Whichever is Longer. [ Time Frame: 28 days of age or when full enteral nutrition is acheived, whichever is longer ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality Rate- Death Rate Before Discharge From the Hospital [ Time Frame: Discharge from the Newborn ICU ] [ Designated as safety issue: Yes ]
  • Incidence of Bronchopulmonary Dysplasia (BPD) [ Time Frame: 36 weeks PMA or discharge home,whichever comes first ] [ Designated as safety issue: Yes ]
  • Incidence of Necrotizing Enterocolitis (NEC) [ Time Frame: At discharge from Newborn ICU ] [ Designated as safety issue: Yes ]
  • Incidence of Retinopathy of Prematurity (ROP) [ Time Frame: At discharge from Newborn ICU ] [ Designated as safety issue: Yes ]
  • Late Onset Sepsis [ Time Frame: At the discharge from Newborn ICU ] [ Designated as safety issue: Yes ]
    Bloodstream infection, defined as a positive blood culture obtained after 72 hours of life.

  • Length of Stay [ Time Frame: At discharge from Newborn ICU/death ] [ Designated as safety issue: Yes ]
    Defines time to discharge or death.

  • Anthropometric Measurements(Body Weight) [ Time Frame: At age of 28 days and at discharge ] [ Designated as safety issue: No ]
    Change in body weight measurement reported in g/week

  • Anthropometric Measurements(Length) [ Time Frame: At age of 28 days and at discharge ] [ Designated as safety issue: No ]
    Change in body length measurement reported in cm/week

  • Anthropometric Measurements(Head Circumference) [ Time Frame: At age of 28 days and at discharge ] [ Designated as safety issue: No ]
    Change in head circumference measurement reported in cm/week


Enrollment: 136
Study Start Date: June 2009
Study Completion Date: January 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 3 gm/kg/day intravenous lipid emulsion Other: Intravenous fat emulsion
An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
Experimental: Intravenous Fat Emulsion-restricted Other: Restriction of intravenous fat emulsion to 1 gm/kg/d
Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 48 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Preterm infants less than or equal to 29 weeks' gestation
  • Age less than 48 hours

Exclusion Criteria:

  • Congenital intrauterine infection, known to be associated with liver involvement and cholestasis
  • Known structural liver abnormalities that are associated with cholestasis
  • Known genetic disorders: trisomy 21, trisomy 13 and trisomy 18
  • Inborn errors of metabolism
  • Infants meeting the criteria for terminal illness (eg, pH < 6.8 > 2 hours)
  • Inability to obtain informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050660

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520-8064
Sponsors and Collaborators
Yale University
University of California, Los Angeles
Feinberg School of Medicine, Northwestern University
Investigators
Principal Investigator: Richard A Ehrenkranz, MD Yale University
  More Information

Publications:
Responsible Party: Richard Ehrenkranz, Professor of Pediatrics, Yale University
ClinicalTrials.gov Identifier: NCT01050660     History of Changes
Other Study ID Numbers: HIC# 0902004803
Study First Received: December 23, 2009
Results First Received: January 21, 2014
Last Updated: October 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Parenteral nutrition associated liver disease
Direct bilirubin
Intravenous fat emulsion
Very low birth weight infants
PNAC

Additional relevant MeSH terms:
Cholestasis
Liver Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014