ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01050660
Recruitment Status : Completed
First Posted : January 15, 2010
Results First Posted : October 28, 2014
Last Update Posted : October 28, 2014
Sponsor:
Collaborators:
University of California, Los Angeles
Feinberg School of Medicine, Northwestern University
Information provided by (Responsible Party):
Richard Ehrenkranz, Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Parenteral Nutrition-Associated Liver Disease
Interventions Other: Intravenous fat emulsion
Other: Restriction of intravenous fat emulsion to 1 gm/kg/d
Enrollment 136
Recruitment Details Bewtween May 2009 -November 2012- infants born and admitted to NICU were enrolled.
Pre-assignment Details  
Arm/Group Title 3 gm/kg/Day Intravenous Lipid Emulsion Intravenous Fat Emulsion-restricted
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 67 69
Completed 67 69
Not Completed 0 0
Arm/Group Title 3 gm/kg/Day Intravenous Lipid Emulsion Intravenous Fat Emulsion-restricted Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 67 69 136
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 69 participants 136 participants
<=18 years
67
 100.0%
69
 100.0%
136
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 69 participants 136 participants
Female
26
  38.8%
23
  33.3%
49
  36.0%
Male
41
  61.2%
46
  66.7%
87
  64.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 67 participants 69 participants 136 participants
67 69 136
Gestational age at enrollement   [1] 
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 67 participants 69 participants 136 participants
26.4  (1.8) 26.6  (1.8) 26.5  (1.8)
[1]
Measure Description: Gestational age, in full completed weeks at enrollement.
1.Primary Outcome
Title The Presence of Cholestasis at Age of 28 Days or When Full Enteral Nutrition is Achieved, Whichever is Longer.
Hide Description [Not Specified]
Time Frame 28 days of age or when full enteral nutrition is acheived, whichever is longer
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Incidence of PNALD at Yale and UCLA NICU prior to the start of the study was around 40%.

Our goal was to decrease incidence by 50%/ Alpha of 5%/ Power of 80% We calculated a sample size of 65 infants in each group

Arm/Group Title 3 gm/kg/Day Intravenous Lipid Emulsion Intravenous Fat Emulsion-restricted
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 67 69
Measure Type: Number
Unit of Measure: participants who developed Cholestasis
39 45
2.Secondary Outcome
Title Mortality Rate- Death Rate Before Discharge From the Hospital
Hide Description [Not Specified]
Time Frame Discharge from the Newborn ICU
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 3 gm/kg/Day Intravenous Lipid Emulsion Intravenous Fat Emulsion-restricted
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 67 69
Measure Type: Number
Unit of Measure: participants
5 6
3.Secondary Outcome
Title Incidence of Bronchopulmonary Dysplasia (BPD)
Hide Description [Not Specified]
Time Frame 36 weeks PMA or discharge home,whichever comes first
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 3 gm/kg/Day Intravenous Lipid Emulsion Intravenous Fat Emulsion-restricted
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 67 69
Measure Type: Number
Unit of Measure: participants who developed BPD
27 26
4.Secondary Outcome
Title Incidence of Necrotizing Enterocolitis (NEC)
Hide Description [Not Specified]
Time Frame At discharge from Newborn ICU
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 3 gm/kg/Day Intravenous Lipid Emulsion Intravenous Fat Emulsion-restricted
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 67 69
Measure Type: Number
Unit of Measure: participants who developed NEC
8 11
5.Secondary Outcome
Title Incidence of Retinopathy of Prematurity (ROP)
Hide Description [Not Specified]
Time Frame At discharge from Newborn ICU
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 3 gm/kg/Day Intravenous Lipid Emulsion Intravenous Fat Emulsion-restricted
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 67 69
Measure Type: Number
Unit of Measure: participants who developed ROP
7 9
6.Secondary Outcome
Title Late Onset Sepsis
Hide Description Bloodstream infection, defined as a positive blood culture obtained after 72 hours of life.
Time Frame At the discharge from Newborn ICU
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 3 gm/kg/Day Intravenous Lipid Emulsion Intravenous Fat Emulsion-restricted
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 67 69
Measure Type: Number
Unit of Measure: participants who developed LOS
3 5
7.Secondary Outcome
Title Length of Stay
Hide Description Defines time to discharge or death.
Time Frame At discharge from Newborn ICU/death
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 3 gm/kg/Day Intravenous Lipid Emulsion Intravenous Fat Emulsion-restricted
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 67 69
Mean (Inter-Quartile Range)
Unit of Measure: Days
81.5
(64.3 to 108.8)
87
(66.5 to 110.8)
8.Secondary Outcome
Title Anthropometric Measurements(Body Weight)
Hide Description Change in body weight measurement reported in g/week
Time Frame At age of 28 days and at discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 3 gm/kg/Day Intravenous Lipid Emulsion Intravenous Fat Emulsion-restricted
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 67 69
Mean (Standard Deviation)
Unit of Measure: g/week
66.6  (34) 62.9  (39)
9.Secondary Outcome
Title Anthropometric Measurements(Length)
Hide Description Change in body length measurement reported in cm/week
Time Frame At age of 28 days and at discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 3 gm/kg/Day Intravenous Lipid Emulsion Intravenous Fat Emulsion-restricted
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 67 69
Mean (Standard Deviation)
Unit of Measure: cm/week
0.8  (0.5) 0.9  (0.5)
10.Secondary Outcome
Title Anthropometric Measurements(Head Circumference)
Hide Description Change in head circumference measurement reported in cm/week
Time Frame At age of 28 days and at discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 3 gm/kg/Day Intravenous Lipid Emulsion Intravenous Fat Emulsion-restricted
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 67 69
Mean (Standard Deviation)
Unit of Measure: cm/week
0.5  (0.3) 0.6  (0.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 3 gm/kg/Day Intravenous Lipid Emulsion Intravenous Fat Emulsion-restricted
Hide Arm/Group Description 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. 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.
All-Cause Mortality
3 gm/kg/Day Intravenous Lipid Emulsion Intravenous Fat Emulsion-restricted
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
3 gm/kg/Day Intravenous Lipid Emulsion Intravenous Fat Emulsion-restricted
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/67 (7.46%)      6/69 (8.70%)    
General disorders     
Mortality prior to discharge  5/67 (7.46%)  5 6/69 (8.70%)  6
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
3 gm/kg/Day Intravenous Lipid Emulsion Intravenous Fat Emulsion-restricted
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/67 (0.00%)      0/69 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Orly Levit
Organization: Yale University
Phone: 203-688-2320
Responsible Party: Richard Ehrenkranz, Yale University
ClinicalTrials.gov Identifier: NCT01050660     History of Changes
Other Study ID Numbers: HIC# 0902004803
First Submitted: December 23, 2009
First Posted: January 15, 2010
Results First Submitted: January 21, 2014
Results First Posted: October 28, 2014
Last Update Posted: October 28, 2014