Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition
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ClinicalTrials.gov Identifier: NCT02663453 |
Recruitment Status :
Completed
First Posted : January 26, 2016
Results First Posted : May 31, 2017
Last Update Posted : June 23, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cholestasis | Drug: multicomponent lipid emulsion Drug: pure soybean oil lipid emulsion | Phase 3 |
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 (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 |

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.
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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 |
- Incidence of Neonatal Cholestasis [ Time Frame: 3 months ]direct bilirubin level of more than 2 mg/dL
- Neonatal Morbidities [ Time Frame: 4 months ]retinopathy of prematurity, bronchopulmonary dysplasia
- 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
- Weight Gain [ Time Frame: up to 24 weeks ]in-hospital weight gain at birth until discharge (gram/day)
- Height Gain [ Time Frame: up to 24 weeks ]in-hospital height gain at birth until discharge (cm/week)
- Head Circumference Gain [ Time Frame: up to 24 weeks ]in-hospital head circumference gain at birth until discharge (cm/week)
- 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
- 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
- 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

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Ages Eligible for Study: | 24 Weeks to 30 Weeks (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02663453
Principal Investigator: | Wilaiporn Techasatid, doctor | Department of Pediatrics, Faculty of Medicine, Thammasat University, 95 Paholyothin Road, Klongluang, Pathumthani, 12120 Thailand. |
Responsible Party: | Dr Wilaiporn Techasatid, Head of Neonatology, Thammasat University |
ClinicalTrials.gov Identifier: | NCT02663453 |
Other Study ID Numbers: |
MTU-EC-PE-1-033/56 |
First Posted: | January 26, 2016 Key Record Dates |
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 |
preterm parenteral nutrition cholestasis fish oil |
Cholestasis Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases |
Soybean oil, phospholipid emulsion Fat Emulsions, Intravenous Parenteral Nutrition Solutions Pharmaceutical Solutions |