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Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition

Primary Purpose

Cholestasis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
multicomponent lipid emulsion
pure soybean oil lipid emulsion
Sponsored by
Thammasat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholestasis focused on measuring preterm, parenteral nutrition, cholestasis, fish oil

Eligibility Criteria

24 Weeks - 30 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inborn infants with a gestational age of less than 30 weeks
  • Who required parenteral nutrition for at least 7 days

Exclusion Criteria:

  • Evidence of congenital infection
  • Perinatal asphyxia
  • Congenital anomalies
  • Severe IVH
  • Thrombocytopenia
  • Shock or circulation failure
  • Renal or hepatic disorders.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    study group

    control group

    Arm Description

    multicomponent lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.

    pure soybean oil lipid emulsion(intralipid) was administered at a dose of 1gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.

    Outcomes

    Primary Outcome Measures

    Incidence of Neonatal Cholestasis
    direct bilirubin level of more than 2 mg/dL

    Secondary Outcome Measures

    Neonatal Morbidities
    retinopathy of prematurity, bronchopulmonary dysplasia
    Incidence of Extrauterine Growth Restriction (EUGR)
    weight that is less than the tenth percentile for corrected gestational age by the time of discharge
    Weight Gain
    in-hospital weight gain at birth until discharge (gram/day)
    Height Gain
    in-hospital height gain at birth until discharge (cm/week)
    Head Circumference Gain
    in-hospital head circumference gain at birth until discharge (cm/week)
    Assessment of Gamma Glutamyltranspeptidase (GGT)
    blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration
    Assessment of Alanine Aminotransferase (ALT)
    blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration
    Assessment of Aspartate Aminotransferase (AST)
    blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration

    Full Information

    First Posted
    January 11, 2016
    Last Updated
    May 30, 2017
    Sponsor
    Thammasat University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02663453
    Brief Title
    Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition
    Official Title
    Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition: A Two-Center, Double-Blind Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2013 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Thammasat University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the effects of a multicomponent lipid emulsion containing 30% soybean oil, 30% medium-chain triglycerides, 25% olive oil, and 15% fish oil with a conventional pure soybean oil lipid emulsion on the incidence of neonatal cholestasis, infant growth, infant morbidity and the biochemical assessment of liver enzymes.
    Detailed Description
    Intravenous lipid emulsions are the major sources of non-protein energy and provision of required essential fatty acids. The reference lipid emulsion, widely used for many years, is prepared from soybean oil, which is rich in omega 6 polyunsaturated fatty acids and phytosterols that contribute to hepatotoxicity and their metabolites result in pro-inflammatory eicosanoid production. Existing evidence strongly supports a pathogenetic role of inflammation and oxidative stress on parenteral nutrition associated liver disease. Subsequent development of lipid emulsions has focused on reducing the amount of soybean oil and replacing it with other oils.Moreover the omega 3 fatty acids from fish oil are metabolized to anti-inflammatory eicosanoids which can prevent inflammatory responses. A novel multicomponent lipid emulsion may prevent liver injury, improve growth and decrease morbidity in preterm infants.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cholestasis
    Keywords
    preterm, parenteral nutrition, cholestasis, fish oil

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    44 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    study group
    Arm Type
    Experimental
    Arm Description
    multicomponent lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.
    Arm Title
    control group
    Arm Type
    Active Comparator
    Arm Description
    pure soybean oil lipid emulsion(intralipid) was administered at a dose of 1gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.
    Intervention Type
    Drug
    Intervention Name(s)
    multicomponent lipid emulsion
    Other Intervention Name(s)
    SMOF lipid
    Intervention Description
    Lipids were first administered at a dose of 1gm/kg/day within 24 hours after birth for both groups; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.
    Intervention Type
    Drug
    Intervention Name(s)
    pure soybean oil lipid emulsion
    Other Intervention Name(s)
    Intralipid
    Intervention Description
    Lipids were first administered at a dose of 1gm/kg/day within 24 hours after birth for both groups; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.
    Primary Outcome Measure Information:
    Title
    Incidence of Neonatal Cholestasis
    Description
    direct bilirubin level of more than 2 mg/dL
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Neonatal Morbidities
    Description
    retinopathy of prematurity, bronchopulmonary dysplasia
    Time Frame
    4 months
    Title
    Incidence of Extrauterine Growth Restriction (EUGR)
    Description
    weight that is less than the tenth percentile for corrected gestational age by the time of discharge
    Time Frame
    up to 24 weeks
    Title
    Weight Gain
    Description
    in-hospital weight gain at birth until discharge (gram/day)
    Time Frame
    up to 24 weeks
    Title
    Height Gain
    Description
    in-hospital height gain at birth until discharge (cm/week)
    Time Frame
    up to 24 weeks
    Title
    Head Circumference Gain
    Description
    in-hospital head circumference gain at birth until discharge (cm/week)
    Time Frame
    up to 24 weeks
    Title
    Assessment of Gamma Glutamyltranspeptidase (GGT)
    Description
    blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration
    Time Frame
    3 month
    Title
    Assessment of Alanine Aminotransferase (ALT)
    Description
    blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration
    Time Frame
    3 month
    Title
    Assessment of Aspartate Aminotransferase (AST)
    Description
    blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration
    Time Frame
    3 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    24 Weeks
    Maximum Age & Unit of Time
    30 Weeks
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Inborn infants with a gestational age of less than 30 weeks Who required parenteral nutrition for at least 7 days Exclusion Criteria: Evidence of congenital infection Perinatal asphyxia Congenital anomalies Severe IVH Thrombocytopenia Shock or circulation failure Renal or hepatic disorders.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wilaiporn Techasatid, doctor
    Organizational Affiliation
    Department of Pediatrics, Faculty of Medicine, Thammasat University, 95 Paholyothin Road, Klongluang, Pathumthani, 12120 Thailand.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    20531018
    Citation
    Tomsits E, Pataki M, Tolgyesi A, Fekete G, Rischak K, Szollar L. Safety and efficacy of a lipid emulsion containing a mixture of soybean oil, medium-chain triglycerides, olive oil, and fish oil: a randomised, double-blind clinical trial in premature infants requiring parenteral nutrition. J Pediatr Gastroenterol Nutr. 2010 Oct;51(4):514-21. doi: 10.1097/MPG.0b013e3181de210c.
    Results Reference
    result
    PubMed Identifier
    22237883
    Citation
    Rayyan M, Devlieger H, Jochum F, Allegaert K. Short-term use of parenteral nutrition with a lipid emulsion containing a mixture of soybean oil, olive oil, medium-chain triglycerides, and fish oil: a randomized double-blind study in preterm infants. JPEN J Parenter Enteral Nutr. 2012 Jan;36(1 Suppl):81S-94S. doi: 10.1177/0148607111424411.
    Results Reference
    result

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    Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition

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