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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Experimental | 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. |
|
| control group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multicomponent lipid emulsion | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Neonatal Cholestasis | direct bilirubin level of more than 2 mg/dL | 3 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilaiporn Techasatid, doctor | Department of Pediatrics, Faculty of Medicine, Thammasat University, 95 Paholyothin Road, Klongluang, Pathumthani, 12120 Thailand. | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20531018 | Result | 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. | |
| 22237883 |
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This study enrolled preterm infants who required parenteral nutrition for at least 7 days from 2 academic medical centers in Bangkok. The last patient completed in December 2015
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group | multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/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 macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day |
| FG001 | Control Group | pure soybean oil lipid emulsion was administered at a dose of 1 gm/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 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Neonatal Cholestasis | direct bilirubin level of more than 2 mg/dL | Posted | Count of Participants | Participants | 3 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Group | multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/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 macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Wilaiporn Techasatid | Thammasat University | 66890339442 | wilaiporn66@gmail.com |
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| ID | Term |
|---|---|
| D002779 | Cholestasis |
| D047928 | Premature Birth |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D007752 | Obstetric Labor, Premature |
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| ID | Term |
|---|---|
| C545823 | soybean oil, phospholipid emulsion |
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|
| pure soybean oil lipid emulsion | Drug | 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. |
|
|
| 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 |
| Result |
| 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. |
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| weeks |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Control Group |
pure soybean oil lipid emulsion was administered at a dose of 1 gm/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 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day |
|
|
| Secondary | Neonatal Morbidities | retinopathy of prematurity, bronchopulmonary dysplasia | Posted | Count of Participants | Participants | 4 months |
|
|
|
| Secondary | Incidence of Extrauterine Growth Restriction (EUGR) | weight that is less than the tenth percentile for corrected gestational age by the time of discharge | Posted | Count of Participants | Participants | up to 24 weeks |
|
|
|
| Secondary | Weight Gain | in-hospital weight gain at birth until discharge (gram/day) | Posted | Mean | Standard Deviation | gram/day | up to 24 weeks |
|
|
|
| Secondary | Height Gain | in-hospital height gain at birth until discharge (cm/week) | Posted | Mean | Standard Deviation | cm/week | up to 24 weeks |
|
|
|
| Secondary | Head Circumference Gain | in-hospital head circumference gain at birth until discharge (cm/week) | Posted | Mean | Standard Deviation | cm/week | up to 24 weeks |
|
|
|
| Secondary | Assessment of Gamma Glutamyltranspeptidase (GGT) | blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration | Posted | Mean | Standard Deviation | U/L | 3 month |
|
|
|
| Secondary | Assessment of Alanine Aminotransferase (ALT) | blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration | Posted | Mean | Standard Deviation | U/L | 3 month |
|
|
|
| Secondary | Assessment of Aspartate Aminotransferase (AST) | blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration | Posted | Mean | Standard Deviation | U/L | 3 month |
|
|
|
| 4 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Control Group | pure soybean oil lipid emulsion was administered at a dose of 1 gm/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 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day | 4 | 22 | 0 | 22 | 0 | 22 |
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| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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