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Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition

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ClinicalTrials.gov Identifier: NCT02663453
Recruitment Status : Completed
First Posted : January 26, 2016
Results First Posted : May 31, 2017
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Wilaiporn Techasatid, Thammasat University

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.

Condition or disease Intervention/treatment Phase
Cholestasis Drug: multicomponent lipid emulsion Drug: pure soybean oil lipid emulsion Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition: A Two-Center, Double-Blind Randomized Clinical Trial
Study Start Date : December 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: study group
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.
Drug: multicomponent lipid emulsion
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.
Other Name: SMOF lipid

Active Comparator: control group
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.
Drug: pure soybean oil lipid emulsion
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.
Other Name: Intralipid




Primary Outcome Measures :
  1. Incidence of Neonatal Cholestasis [ Time Frame: 3 months ]
    direct bilirubin level of more than 2 mg/dL


Secondary Outcome Measures :
  1. Neonatal Morbidities [ Time Frame: 4 months ]
    retinopathy of prematurity, bronchopulmonary dysplasia

  2. Incidence of Extrauterine Growth Restriction (EUGR) [ Time Frame: up to 24 weeks ]
    weight that is less than the tenth percentile for corrected gestational age by the time of discharge

  3. Weight Gain [ Time Frame: up to 24 weeks ]
    in-hospital weight gain at birth until discharge (gram/day)

  4. Height Gain [ Time Frame: up to 24 weeks ]
    in-hospital height gain at birth until discharge (cm/week)

  5. Head Circumference Gain [ Time Frame: up to 24 weeks ]
    in-hospital head circumference gain at birth until discharge (cm/week)

  6. Assessment of Gamma Glutamyltranspeptidase (GGT) [ Time Frame: 3 month ]
    blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration

  7. Assessment of Alanine Aminotransferase (ALT) [ Time Frame: 3 month ]
    blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration

  8. Assessment of Aspartate Aminotransferase (AST) [ Time Frame: 3 month ]
    blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration



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Ages Eligible for Study:   24 Weeks to 30 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02663453


Sponsors and Collaborators
Thammasat University
Investigators
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Principal Investigator: Wilaiporn Techasatid, doctor Department of Pediatrics, Faculty of Medicine, Thammasat University, 95 Paholyothin Road, Klongluang, Pathumthani, 12120 Thailand.

Publications of Results:
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Responsible Party: Dr Wilaiporn Techasatid, Head of Neonatology, Thammasat University
ClinicalTrials.gov Identifier: NCT02663453     History of Changes
Other Study ID Numbers: MTU-EC-PE-1-033/56
First Posted: January 26, 2016    Key Record Dates
Results First Posted: May 31, 2017
Last Update Posted: June 23, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr Wilaiporn Techasatid, Thammasat University:
preterm
parenteral nutrition
cholestasis
fish oil
Additional relevant MeSH terms:
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Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions