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Trial record 61 of 179 for:    Phospholipids

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
Sponsor:
Information provided by (Responsible Party):
Dr Wilaiporn Techasatid, Thammasat University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Cholestasis
Interventions Drug: multicomponent lipid emulsion
Drug: pure soybean oil lipid emulsion
Enrollment 44
Recruitment Details 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
Pre-assignment Details  
Arm/Group Title Study Group Control Group
Hide Arm/Group Description 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

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

Period Title: Overall Study
Started 22 22
Completed 17 18
Not Completed 5 4
Reason Not Completed
Death             4             4
Withdrawal by Subject             1             0
Arm/Group Title Study Group Control Group Total
Hide Arm/Group Description

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 22 22 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 22 participants 22 participants 44 participants
27.6  (2.2) 28.4  (1.2) 28.0  (1.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
Female
14
  63.6%
14
  63.6%
28
  63.6%
Male
8
  36.4%
8
  36.4%
16
  36.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Thailand Number Analyzed 22 participants 22 participants 44 participants
22 22 44
1.Primary Outcome
Title Incidence of Neonatal Cholestasis
Hide Description direct bilirubin level of more than 2 mg/dL
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:
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

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

Overall Number of Participants Analyzed 22 22
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.5%
2
   9.1%
2.Secondary Outcome
Title Neonatal Morbidities
Hide Description retinopathy of prematurity, bronchopulmonary dysplasia
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:
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

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

Overall Number of Participants Analyzed 22 22
Measure Type: Count of Participants
Unit of Measure: Participants
retinopathy of prematurity
7
  31.8%
6
  27.3%
bronchopulmonary dysplasia
10
  45.5%
9
  40.9%
3.Secondary Outcome
Title Incidence of Extrauterine Growth Restriction (EUGR)
Hide Description weight that is less than the tenth percentile for corrected gestational age by the time of discharge
Time Frame up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:
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

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

Overall Number of Participants Analyzed 22 22
Measure Type: Count of Participants
Unit of Measure: Participants
8
  36.4%
12
  54.5%
4.Secondary Outcome
Title Weight Gain
Hide Description in-hospital weight gain at birth until discharge (gram/day)
Time Frame up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:
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

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

Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: gram/day
19.7  (3.9) 18.8  (3.9)
5.Secondary Outcome
Title Height Gain
Hide Description in-hospital height gain at birth until discharge (cm/week)
Time Frame up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:
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

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

Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: cm/week
0.9  (0.2) 0.8  (0.2)
6.Secondary Outcome
Title Head Circumference Gain
Hide Description in-hospital head circumference gain at birth until discharge (cm/week)
Time Frame up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:
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

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

Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: cm/week
0.7  (0.2) 0.7  (0.2)
7.Secondary Outcome
Title Assessment of Gamma Glutamyltranspeptidase (GGT)
Hide Description blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration
Time Frame 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:
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

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

Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: U/L
before enrollment 134.7  (113.8) 138.7  (62.6)
week 1 73.8  (58.8) 79.5  (45.4)
week 2 63.1  (47.5) 68.6  (43.5)
week 3 94.0  (68.3) 95.4  (85.2)
8.Secondary Outcome
Title Assessment of Alanine Aminotransferase (ALT)
Hide Description blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration
Time Frame 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:
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

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

Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: U/L
before enrollment 16.3  (12.8) 15.1  (7.1)
week 1 14.7  (7.8) 15.1  (7.2)
week 2 17.1  (8.7) 19.8  (13.3)
week 3 17.5  (6.8) 17.7  (7.9)
9.Secondary Outcome
Title Assessment of Aspartate Aminotransferase (AST)
Hide Description blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration
Time Frame 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:
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

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

Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: U/L
before enrollment 61.8  (21.6) 55.6  (28.1)
week 1 26.5  (22.0) 26.0  (9.6)
week 2 26.2  (8.0) 24.4  (6.2)
week 3 24.2  (3.7) 25.9  (8.8)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Group Control Group
Hide Arm/Group Description 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

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

All-Cause Mortality
Study Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   4/22 (18.18%)   4/22 (18.18%) 
Show Serious Adverse Events Hide Serious Adverse Events
Study Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Study Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr.Wilaiporn Techasatid
Organization: Thammasat University
Phone: 66890339442
Responsible Party: Dr Wilaiporn Techasatid, Thammasat University
ClinicalTrials.gov Identifier: NCT02663453     History of Changes
Other Study ID Numbers: MTU-EC-PE-1-033/56
First Submitted: January 11, 2016
First Posted: January 26, 2016
Results First Submitted: April 30, 2017
Results First Posted: May 31, 2017
Last Update Posted: June 23, 2017