Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition

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

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.

Study Overview

• Status: Completed
• Conditions: Cholestasis
• Intervention / Treatment: Drug: multicomponent lipid emulsion; Drug: pure soybean oil lipid emulsion

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Intralipid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Neonatal Cholestasis	direct bilirubin level of more than 2 mg/dL	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal Morbidities	retinopathy of prematurity, bronchopulmonary dysplasia	4 months
Incidence of Extrauterine Growth Restriction (EUGR)	weight that is less than the tenth percentile for corrected gestational age by the time of discharge	up to 24 weeks
Weight Gain	in-hospital weight gain at birth until discharge (gram/day)	up to 24 weeks
Height Gain	in-hospital height gain at birth until discharge (cm/week)	up to 24 weeks
Head Circumference Gain	in-hospital head circumference gain at birth until discharge (cm/week)	up to 24 weeks
Assessment of Gamma Glutamyltranspeptidase (GGT)	blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration	3 month
Assessment of Alanine Aminotransferase (ALT)	blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration	3 month
Assessment of Aspartate Aminotransferase (AST)	blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration	3 month

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: January 11, 2016
• First Submitted That Met QC Criteria: January 21, 2016
• First Posted (Estimate): January 26, 2016

Study Record Updates

• Last Update Posted (Actual): June 23, 2017
• Last Update Submitted That Met QC Criteria: May 30, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: preterm; fish oil; parenteral nutrition; cholestasis
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholestasis; Pharmaceutical Solutions; Parenteral Nutrition Solutions; Fat Emulsions, Intravenous; Soybean oil, phospholipid emulsion
• Other Study ID Numbers: MTU-EC-PE-1-033/56

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO