Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition
- Conditions
- Cholestasis
- Interventions
- Drug: multicomponent lipid emulsion
- Registration Number
- NCT02663453
- Lead Sponsor
- Thammasat University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- Inborn infants with a gestational age of less than 30 weeks
- Who required parenteral nutrition for at least 7 days
- Evidence of congenital infection
- Perinatal asphyxia
- Congenital anomalies
- Severe IVH
- Thrombocytopenia
- Shock or circulation failure
- Renal or hepatic disorders.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group pure soybean oil lipid emulsion 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. study group multicomponent lipid emulsion 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.
- Primary Outcome Measures
Name Time Method Incidence of Neonatal Cholestasis 3 months direct bilirubin level of more than 2 mg/dL
- Secondary Outcome Measures
Name Time Method Weight Gain up to 24 weeks in-hospital weight gain at birth until discharge (gram/day)
Height Gain up to 24 weeks in-hospital height gain at birth until discharge (cm/week)
Neonatal Morbidities 4 months retinopathy of prematurity, bronchopulmonary dysplasia
Incidence of Extrauterine Growth Restriction (EUGR) up to 24 weeks weight that is less than the tenth percentile for corrected gestational age by the time of discharge
Head Circumference Gain up to 24 weeks in-hospital head circumference gain at birth until discharge (cm/week)
Assessment of Aspartate Aminotransferase (AST) 3 month blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration
Assessment of Gamma Glutamyltranspeptidase (GGT) 3 month blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration
Assessment of Alanine Aminotransferase (ALT) 3 month blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration