Trial Outcomes & Findings for Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition (NCT NCT02663453)
NCT ID: NCT02663453
Last Updated: 2017-06-23
Results Overview
direct bilirubin level of more than 2 mg/dL
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
44 participants
Primary outcome timeframe
3 months
Results posted on
2017-06-23
Participant Flow
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
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
17
|
18
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Death
|
4
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition
Baseline characteristics by cohort
| Measure |
Study Group
n=22 Participants
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.
|
Control Group
n=22 Participants
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
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.6 weeks
STANDARD_DEVIATION 2.2 • n=99 Participants
|
28.4 weeks
STANDARD_DEVIATION 1.2 • n=107 Participants
|
28.0 weeks
STANDARD_DEVIATION 1.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Region of Enrollment
Thailand
|
22 participants
n=99 Participants
|
22 participants
n=107 Participants
|
44 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsdirect bilirubin level of more than 2 mg/dL
Outcome measures
| Measure |
Study Group
n=22 Participants
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
|
Control Group
n=22 Participants
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
|
|---|---|---|
|
Incidence of Neonatal Cholestasis
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 4 monthsretinopathy of prematurity, bronchopulmonary dysplasia
Outcome measures
| Measure |
Study Group
n=22 Participants
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
|
Control Group
n=22 Participants
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
|
|---|---|---|
|
Neonatal Morbidities
retinopathy of prematurity
|
7 Participants
|
6 Participants
|
|
Neonatal Morbidities
bronchopulmonary dysplasia
|
10 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: up to 24 weeksweight that is less than the tenth percentile for corrected gestational age by the time of discharge
Outcome measures
| Measure |
Study Group
n=22 Participants
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
|
Control Group
n=22 Participants
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
|
|---|---|---|
|
Incidence of Extrauterine Growth Restriction (EUGR)
|
8 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: up to 24 weeksin-hospital weight gain at birth until discharge (gram/day)
Outcome measures
| Measure |
Study Group
n=22 Participants
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
|
Control Group
n=22 Participants
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
|
|---|---|---|
|
Weight Gain
|
19.7 gram/day
Standard Deviation 3.9
|
18.8 gram/day
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: up to 24 weeksin-hospital height gain at birth until discharge (cm/week)
Outcome measures
| Measure |
Study Group
n=22 Participants
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
|
Control Group
n=22 Participants
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
|
|---|---|---|
|
Height Gain
|
0.9 cm/week
Standard Deviation 0.2
|
0.8 cm/week
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: up to 24 weeksin-hospital head circumference gain at birth until discharge (cm/week)
Outcome measures
| Measure |
Study Group
n=22 Participants
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
|
Control Group
n=22 Participants
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
|
|---|---|---|
|
Head Circumference Gain
|
0.7 cm/week
Standard Deviation 0.2
|
0.7 cm/week
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: 3 monthblood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration
Outcome measures
| Measure |
Study Group
n=22 Participants
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
|
Control Group
n=22 Participants
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
|
|---|---|---|
|
Assessment of Gamma Glutamyltranspeptidase (GGT)
before enrollment
|
134.7 U/L
Standard Deviation 113.8
|
138.7 U/L
Standard Deviation 62.6
|
|
Assessment of Gamma Glutamyltranspeptidase (GGT)
week 1
|
73.8 U/L
Standard Deviation 58.8
|
79.5 U/L
Standard Deviation 45.4
|
|
Assessment of Gamma Glutamyltranspeptidase (GGT)
week 2
|
63.1 U/L
Standard Deviation 47.5
|
68.6 U/L
Standard Deviation 43.5
|
|
Assessment of Gamma Glutamyltranspeptidase (GGT)
week 3
|
94.0 U/L
Standard Deviation 68.3
|
95.4 U/L
Standard Deviation 85.2
|
SECONDARY outcome
Timeframe: 3 monthblood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration
Outcome measures
| Measure |
Study Group
n=22 Participants
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
|
Control Group
n=22 Participants
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
|
|---|---|---|
|
Assessment of Alanine Aminotransferase (ALT)
before enrollment
|
16.3 U/L
Standard Deviation 12.8
|
15.1 U/L
Standard Deviation 7.1
|
|
Assessment of Alanine Aminotransferase (ALT)
week 1
|
14.7 U/L
Standard Deviation 7.8
|
15.1 U/L
Standard Deviation 7.2
|
|
Assessment of Alanine Aminotransferase (ALT)
week 2
|
17.1 U/L
Standard Deviation 8.7
|
19.8 U/L
Standard Deviation 13.3
|
|
Assessment of Alanine Aminotransferase (ALT)
week 3
|
17.5 U/L
Standard Deviation 6.8
|
17.7 U/L
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: 3 monthblood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration
Outcome measures
| Measure |
Study Group
n=22 Participants
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
|
Control Group
n=22 Participants
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
|
|---|---|---|
|
Assessment of Aspartate Aminotransferase (AST)
week 1
|
26.5 U/L
Standard Deviation 22.0
|
26.0 U/L
Standard Deviation 9.6
|
|
Assessment of Aspartate Aminotransferase (AST)
before enrollment
|
61.8 U/L
Standard Deviation 21.6
|
55.6 U/L
Standard Deviation 28.1
|
|
Assessment of Aspartate Aminotransferase (AST)
week 2
|
26.2 U/L
Standard Deviation 8.0
|
24.4 U/L
Standard Deviation 6.2
|
|
Assessment of Aspartate Aminotransferase (AST)
week 3
|
24.2 U/L
Standard Deviation 3.7
|
25.9 U/L
Standard Deviation 8.8
|
Adverse Events
Study Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place