Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition

• 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: Thammasat University
• Information provided by (Responsible Party): Dr Wilaiporn Techasatid, Thammasat University

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Sponsors and Collaborators

Thammasat University

Investigators

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

More Information

Publications of 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.

• 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
• 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:

Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Soybean oil, phospholipid emulsion; Fat Emulsions, Intravenous; Parenteral Nutrition Solutions; Pharmaceutical Solutions