Clinical trial NCT02663453: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cholestasis
Keywords: preterm
parenteral nutrition
cholestasis
fish oil
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2016-01-26
Enrollment: 44
Sex: ALL
Minimum age (years): 24
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of Neonatal Cholestasis
timeFrame: 3 months
Secondary outcomes:
measure: Neonatal Morbidities
timeFrame: 4 months
measure: Incidence of Extrauterine Growth Restriction (EUGR)
timeFrame: up to 24 weeks
measure: Weight Gain
timeFrame: up to 24 weeks
measure: Height Gain
timeFrame: up to 24 weeks
measure: Head Circumference Gain
timeFrame: up to 24 weeks
measure: Assessment of Gamma Glutamyltranspeptidase (GGT)
timeFrame: 3 month
measure: Assessment of Alanine Aminotransferase (ALT)
timeFrame: 3 month
measure: Assessment of Aspartate Aminotransferase (AST)
timeFrame: 3 month
Other outcomes:
Locations:
Study officials:
affiliation: Department of Pediatrics, Faculty of Medicine, Thammasat University, 95 Paholyothin Road, Klongluang, Pathumthani, 12120 Thailand.
name: Wilaiporn Techasatid, doctor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.