Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition

Overview

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.

Full Title of Study: “Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition: A Two-Center, Double-Blind Randomized Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: December 2015

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of Neonatal Cholestasis
    • Time Frame: 3 months
    • direct bilirubin level of more than 2 mg/dL

Secondary Measures

  • Neonatal Morbidities
    • Time Frame: 4 months
    • retinopathy of prematurity, bronchopulmonary dysplasia
  • 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
  • Weight Gain
    • Time Frame: up to 24 weeks
    • in-hospital weight gain at birth until discharge (gram/day)
  • Height Gain
    • Time Frame: up to 24 weeks
    • in-hospital height gain at birth until discharge (cm/week)
  • Head Circumference Gain
    • Time Frame: up to 24 weeks
    • in-hospital head circumference gain at birth until discharge (cm/week)
  • 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
  • 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
  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 24 Weeks

Maximum Age: 30 Weeks

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Thammasat University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr Wilaiporn Techasatid, Head of Neonatology – Thammasat University
  • Overall Official(s)
    • Wilaiporn Techasatid, doctor, Principal Investigator, Department of Pediatrics, Faculty of Medicine, Thammasat University, 95 Paholyothin Road, Klongluang, Pathumthani, 12120 Thailand.

Citations Reporting on Results

Tomsits E, Pataki M, Tölgyesi A, Fekete G, Rischak K, Szollár 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.

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.

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