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
Results First Received: January 21, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Bewtween May 2009 -November 2012- infants born and admitted to NICU were enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
3 gm/kg/Day Intravenous Lipid Emulsion 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.
Intravenous Fat Emulsion-restricted 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.

Participant Flow:   Overall Study
    3 gm/kg/Day Intravenous Lipid Emulsion     Intravenous Fat Emulsion-restricted  
STARTED     67     69  
COMPLETED     67     69  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
3 gm/kg/Day Intravenous Lipid Emulsion 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.
Intravenous Fat Emulsion-restricted 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 Total of all reporting groups

Baseline Measures
    3 gm/kg/Day Intravenous Lipid Emulsion     Intravenous Fat Emulsion-restricted     Total  
Number of Participants  
[units: participants]
  67     69     136  
Age  
[units: participants]
     
<=18 years     67     69     136  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     26     23     49  
Male     41     46     87  
Region of Enrollment  
[units: participants]
     
United States     67     69     136  
Gestational age at enrollement [1]
[units: weeks]
Mean ± Standard Deviation
  26.4  ± 1.8     26.6  ± 1.8     26.5  ± 1.8  
[1] Gestational age, in full completed weeks at enrollement.



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Mortality Rate- Death Rate Before Discharge From the Hospital   [ Time Frame: Discharge from the Newborn ICU ]

3.  Secondary:   Incidence of Bronchopulmonary Dysplasia (BPD)   [ Time Frame: 36 weeks PMA or discharge home,whichever comes first ]

4.  Secondary:   Incidence of Necrotizing Enterocolitis (NEC)   [ Time Frame: At discharge from Newborn ICU ]

5.  Secondary:   Incidence of Retinopathy of Prematurity (ROP)   [ Time Frame: At discharge from Newborn ICU ]

6.  Secondary:   Late Onset Sepsis   [ Time Frame: At the discharge from Newborn ICU ]

7.  Secondary:   Length of Stay   [ Time Frame: At discharge from Newborn ICU/death ]

8.  Secondary:   Anthropometric Measurements(Body Weight)   [ Time Frame: At age of 28 days and at discharge ]

9.  Secondary:   Anthropometric Measurements(Length)   [ Time Frame: At age of 28 days and at discharge ]

10.  Secondary:   Anthropometric Measurements(Head Circumference)   [ Time Frame: At age of 28 days and at discharge ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: orly.levit@yale.edu


Publications:

Responsible Party: Richard Ehrenkranz, 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