Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cholestasis

Intervention / Treatment
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* Drug: multicomponent lipid emulsion
* Drug: pure soybean oil lipid emulsion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 24 Weeks
Maximum Age: 30 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>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<br>* 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.<br>* Other names: SMOF lipid;|
| Active Comparator: control group<br>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<br>* 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.<br>* Other names: Intralipid;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm, parenteral nutrition, cholestasis, fish oil