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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Southern California
Feinberg School of Medicine, Northwestern University
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT01050660
First received: December 23, 2009
Last updated: January 14, 2010
Last verified: January 2010
  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 Cholestasis
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 [ Time Frame: Discharge from the Newborn ICU ] [ Designated as safety issue: No ]
  • Incidence of bronchopulmonary dysplasia (BPD) [ Time Frame: 36 weeks PMA or discharge home,whichever comes first ] [ Designated as safety issue: No ]
  • Incidence of necrotizing enterocolitis (NEC) [ Time Frame: At discharge from Newborn ICU ] [ Designated as safety issue: No ]
  • Incidence of retinopathy of prematurity (ROP) [ Time Frame: At discharge from Newborn ICU ] [ Designated as safety issue: No ]
  • Late onset sepsis [ Time Frame: At the discharge from Newborn ICU ] [ Designated as safety issue: No ]
  • Length of stay [ Time Frame: At discharge from Newborn ICU ] [ Designated as safety issue: No ]
  • Time to regain birth weight [ Time Frame: Time necessary to return to the birth weight ] [ Designated as safety issue: No ]
  • Anthropometric measurements(body weight, length, head circumference) [ Time Frame: At age of 28 days and at discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: June 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: June 2011 (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.

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  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

Contacts
Contact: Richard A Ehrenkranz, MD 203-688-2320 richard.ehrenkranz@yale.edu
Contact: Orly Levit, MD 203-688-2320 orly.levit@yale.edu

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

Publications:
Responsible Party: Richard A. Ehrenkranz, MD, Professor of Pediatrics, Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT01050660     History of Changes
Other Study ID Numbers: HIC# 0902004803
Study First Received: December 23, 2009
Last Updated: January 14, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 01, 2014