Trial Outcomes & Findings for Comparison of Two Different Lipid Emulsions for Parenteral Nutrition in Preterm Infants (NCT NCT00497289)
NCT ID: NCT00497289
Last Updated: 2021-03-10
Results Overview
Change in ALT between pre/post treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
on Study day -1 & 6
Results posted on
2021-03-10
Participant Flow
Participant milestones
| Measure |
Lipidem 20 %
Lipidem 20 %
Lipidem 20%: daily i.v. infusion for up to 5 days
|
Lipofundin MCT/LCT 20%
Lipofundin MCT/LCT 20%
Lipofundin MCT/LCT 20 %: daily i.v. infusion for up to 5 days
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Two Different Lipid Emulsions for Parenteral Nutrition in Preterm Infants
Baseline characteristics by cohort
| Measure |
MCT:LCT:FO / 5:4:1
n=24 Participants
Lipidem 20%: daily i.v. infusion for up to 5 days
|
MCT:LCT / 1:1
n=24 Participants
Lipofundin MCT/LCT 20 %: daily i.v. infusion for up to 5 days
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
12.38 hours
STANDARD_DEVIATION 19.38 • n=5 Participants
|
13.74 hours
STANDARD_DEVIATION 21.89 • n=7 Participants
|
13.06 hours
STANDARD_DEVIATION 20.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: on Study day -1 & 6Population: A duration of treatment with study medication over less than 6 days was regarded as the only major deviation from the protocol. Therefore all available values were used for analysis.
Change in ALT between pre/post treatment
Outcome measures
| Measure |
MCT:LCT:FO / 5:4:1
n=15 Participants
Lipidem 20%: daily i.v. infusion for up to 5 days
|
MCT:LCT / 1:1
n=19 Participants
Lipofundin MCT/LCT 20 %: daily i.v. infusion for up to 5 days
|
|---|---|---|
|
Safety: Alanine Transaminase (ALT)
|
-0.83 U/L
Standard Deviation 4.61
|
-3.27 U/L
Standard Deviation 7.81
|
PRIMARY outcome
Timeframe: on Study day -1 & 6Population: Per protocol population
Change of IL-6 Measurement pre/post treatment
Outcome measures
| Measure |
MCT:LCT:FO / 5:4:1
n=19 Participants
Lipidem 20%: daily i.v. infusion for up to 5 days
|
MCT:LCT / 1:1
n=17 Participants
Lipofundin MCT/LCT 20 %: daily i.v. infusion for up to 5 days
|
|---|---|---|
|
Efficacy: Interleukin-6 (IL-6)
|
-42.23 pg/mL
Standard Deviation 197.10
|
-68.74 pg/mL
Standard Deviation 101.67
|
Adverse Events
MCT/LCT/FO-containing 20% Fat Emulsion
Serious events: 22 serious events
Other events: 24 other events
Deaths: 0 deaths
MCT/LCT Emulsion (20%)
Serious events: 19 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MCT/LCT/FO-containing 20% Fat Emulsion
n=24 participants at risk
Preterm infants received a study treatment by parenteral route with MCT/LCT/FO
Lipidem 20%: daily i.v. infusion for up to 6 days
|
MCT/LCT Emulsion (20%)
n=24 participants at risk
Preterm infants received a study treatment by parenteral route with MCT/LCT
Lipofundin MCT/LCT 20 %: daily i.v. infusion for up to 6 days
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
12.5%
3/24 • Number of events 3 • From enrolment into study at least 6 days or longer if medically indicated.
|
8.3%
2/24 • Number of events 2 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Infections and infestations
Neonatal infection
|
4.2%
1/24 • Number of events 1 • From enrolment into study at least 6 days or longer if medically indicated.
|
0.00%
0/24 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Infections and infestations
Amniotic infection syndrome of Blane
|
8.3%
2/24 • Number of events 2 • From enrolment into study at least 6 days or longer if medically indicated.
|
0.00%
0/24 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis neonatal
|
4.2%
1/24 • Number of events 1 • From enrolment into study at least 6 days or longer if medically indicated.
|
0.00%
0/24 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Cardiac disorders
Bradycardia neonatal
|
4.2%
1/24 • Number of events 1 • From enrolment into study at least 6 days or longer if medically indicated.
|
0.00%
0/24 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
|
16.7%
4/24 • Number of events 4 • From enrolment into study at least 6 days or longer if medically indicated.
|
0.00%
0/24 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Investigations
C-reactive protein increased
|
8.3%
2/24 • Number of events 2 • From enrolment into study at least 6 days or longer if medically indicated.
|
8.3%
2/24 • Number of events 2 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Investigations
Blood glucose decreased
|
4.2%
1/24 • Number of events 1 • From enrolment into study at least 6 days or longer if medically indicated.
|
0.00%
0/24 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Nervous system disorders
Hemorrhage intracranial
|
4.2%
1/24 • Number of events 1 • From enrolment into study at least 6 days or longer if medically indicated.
|
8.3%
2/24 • Number of events 2 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Investigations
Interleukin level increased
|
4.2%
1/24 • Number of events 1 • From enrolment into study at least 6 days or longer if medically indicated.
|
8.3%
2/24 • Number of events 2 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
4.2%
1/24 • Number of events 1 • From enrolment into study at least 6 days or longer if medically indicated.
|
0.00%
0/24 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
|
62.5%
15/24 • Number of events 15 • From enrolment into study at least 6 days or longer if medically indicated.
|
58.3%
14/24 • Number of events 14 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
4.2%
1/24 • Number of events 1 • From enrolment into study at least 6 days or longer if medically indicated.
|
0.00%
0/24 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Congenital, familial and genetic disorders
Congenital pneumonia
|
4.2%
1/24 • Number of events 1 • From enrolment into study at least 6 days or longer if medically indicated.
|
0.00%
0/24 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory failure
|
4.2%
1/24 • Number of events 1 • From enrolment into study at least 6 days or longer if medically indicated.
|
0.00%
0/24 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
General disorders
Systemic inflammatory response syndrome
|
4.2%
1/24 • Number of events 1 • From enrolment into study at least 6 days or longer if medically indicated.
|
0.00%
0/24 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Infections and infestations
Ureaplasma infection
|
4.2%
1/24 • Number of events 1 • From enrolment into study at least 6 days or longer if medically indicated.
|
0.00%
0/24 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/24 • From enrolment into study at least 6 days or longer if medically indicated.
|
4.2%
1/24 • Number of events 2 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Infections and infestations
Sepsis neonatal
|
0.00%
0/24 • From enrolment into study at least 6 days or longer if medically indicated.
|
4.2%
1/24 • Number of events 1 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Gastrointestinal disorders
Ileal stenosis
|
0.00%
0/24 • From enrolment into study at least 6 days or longer if medically indicated.
|
4.2%
1/24 • Number of events 1 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Congenital, familial and genetic disorders
Congenital inguinal hernia
|
0.00%
0/24 • From enrolment into study at least 6 days or longer if medically indicated.
|
4.2%
1/24 • Number of events 1 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/24 • From enrolment into study at least 6 days or longer if medically indicated.
|
4.2%
1/24 • Number of events 1 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Gastrointestinal disorders
Necrotising enterocolitis neonatal
|
0.00%
0/24 • From enrolment into study at least 6 days or longer if medically indicated.
|
4.2%
1/24 • Number of events 1 • From enrolment into study at least 6 days or longer if medically indicated.
|
Other adverse events
| Measure |
MCT/LCT/FO-containing 20% Fat Emulsion
n=24 participants at risk
Preterm infants received a study treatment by parenteral route with MCT/LCT/FO
Lipidem 20%: daily i.v. infusion for up to 6 days
|
MCT/LCT Emulsion (20%)
n=24 participants at risk
Preterm infants received a study treatment by parenteral route with MCT/LCT
Lipofundin MCT/LCT 20 %: daily i.v. infusion for up to 6 days
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia neonatal
|
4.2%
1/24 • Number of events 1 • From enrolment into study at least 6 days or longer if medically indicated.
|
8.3%
2/24 • Number of events 2 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Cardiac disorders
Bradycardia neonatal
|
83.3%
20/24 • Number of events 20 • From enrolment into study at least 6 days or longer if medically indicated.
|
70.8%
17/24 • Number of events 17 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Congenital, familial and genetic disorders
Congenital methemoglobinemia
|
50.0%
12/24 • Number of events 12 • From enrolment into study at least 6 days or longer if medically indicated.
|
54.2%
13/24 • Number of events 13 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Eye disorders
Eyelid oedema
|
8.3%
2/24 • Number of events 2 • From enrolment into study at least 6 days or longer if medically indicated.
|
0.00%
0/24 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Gastrointestinal disorders
Hematemesis
|
0.00%
0/24 • From enrolment into study at least 6 days or longer if medically indicated.
|
8.3%
2/24 • Number of events 2 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
General disorders
Infusion site erythema
|
8.3%
2/24 • Number of events 2 • From enrolment into study at least 6 days or longer if medically indicated.
|
4.2%
1/24 • Number of events 1 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
General disorders
Oedema peripheral
|
4.2%
1/24 • Number of events 1 • From enrolment into study at least 6 days or longer if medically indicated.
|
8.3%
2/24 • Number of events 4 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Infections and infestations
Amniotic infection syndrome of Blane
|
8.3%
2/24 • Number of events 2 • From enrolment into study at least 6 days or longer if medically indicated.
|
0.00%
0/24 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Infections and infestations
Escherichia infection
|
8.3%
2/24 • Number of events 2 • From enrolment into study at least 6 days or longer if medically indicated.
|
0.00%
0/24 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Injury, poisoning and procedural complications
Skin injury
|
4.2%
1/24 • Number of events 1 • From enrolment into study at least 6 days or longer if medically indicated.
|
12.5%
3/24 • Number of events 3 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
8.3%
2/24 • Number of events 2 • From enrolment into study at least 6 days or longer if medically indicated.
|
8.3%
2/24 • Number of events 2 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Investigations
Base excess increased
|
12.5%
3/24 • Number of events 3 • From enrolment into study at least 6 days or longer if medically indicated.
|
4.2%
1/24 • Number of events 1 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Investigations
Bilirubin conjugated increased
|
45.8%
11/24 • Number of events 11 • From enrolment into study at least 6 days or longer if medically indicated.
|
54.2%
13/24 • Number of events 13 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Investigations
Blood creatinine increased
|
4.2%
1/24 • Number of events 1 • From enrolment into study at least 6 days or longer if medically indicated.
|
8.3%
2/24 • Number of events 2 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Investigations
Blood glucose increased
|
100.0%
24/24 • Number of events 24 • From enrolment into study at least 6 days or longer if medically indicated.
|
91.7%
22/24 • Number of events 22 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Investigations
Blood lactic acid increased
|
62.5%
15/24 • Number of events 15 • From enrolment into study at least 6 days or longer if medically indicated.
|
66.7%
16/24 • Number of events 16 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Investigations
Blood triglycerides increased
|
20.8%
5/24 • Number of events 5 • From enrolment into study at least 6 days or longer if medically indicated.
|
33.3%
8/24 • Number of events 8 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Investigations
Body temperature increased
|
12.5%
3/24 • Number of events 3 • From enrolment into study at least 6 days or longer if medically indicated.
|
4.2%
1/24 • Number of events 1 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Investigations
C-reactive protein increased
|
20.8%
5/24 • Number of events 5 • From enrolment into study at least 6 days or longer if medically indicated.
|
20.8%
5/24 • Number of events 5 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Investigations
Hemoglobin decreased
|
29.2%
7/24 • Number of events 7 • From enrolment into study at least 6 days or longer if medically indicated.
|
25.0%
6/24 • Number of events 6 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Investigations
Interleukin level increased
|
79.2%
19/24 • Number of events 19 • From enrolment into study at least 6 days or longer if medically indicated.
|
75.0%
18/24 • Number of events 18 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Investigations
Oxygen saturation decreased
|
20.8%
5/24 • Number of events 5 • From enrolment into study at least 6 days or longer if medically indicated.
|
8.3%
2/24 • Number of events 2 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Investigations
Platelet count decreased
|
33.3%
8/24 • Number of events 8 • From enrolment into study at least 6 days or longer if medically indicated.
|
33.3%
8/24 • Number of events 8 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Investigations
Prothrombin level decreased
|
8.3%
2/24 • Number of events 2 • From enrolment into study at least 6 days or longer if medically indicated.
|
0.00%
0/24 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Investigations
Prothrombin level increased
|
16.7%
4/24 • Number of events 4 • From enrolment into study at least 6 days or longer if medically indicated.
|
25.0%
6/24 • Number of events 6 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Investigations
Red blood cell count decreased
|
45.8%
11/24 • Number of events 11 • From enrolment into study at least 6 days or longer if medically indicated.
|
62.5%
15/24 • Number of events 15 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Investigations
Reticulocyte count increased
|
62.5%
15/24 • Number of events 15 • From enrolment into study at least 6 days or longer if medically indicated.
|
62.5%
15/24 • Number of events 15 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Investigations
White blood cell analysis decreased
|
33.3%
8/24 • Number of events 8 • From enrolment into study at least 6 days or longer if medically indicated.
|
29.2%
7/24 • Number of events 7 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Investigations
White blood cell analysis increased
|
16.7%
4/24 • Number of events 4 • From enrolment into study at least 6 days or longer if medically indicated.
|
12.5%
3/24 • Number of events 3 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Respiratory, thoracic and mediastinal disorders
Infantile apnoeic attack
|
8.3%
2/24 • Number of events 2 • From enrolment into study at least 6 days or longer if medically indicated.
|
12.5%
3/24 • Number of events 3 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory acidosis
|
0.00%
0/24 • From enrolment into study at least 6 days or longer if medically indicated.
|
8.3%
2/24 • Number of events 2 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder neonatal
|
8.3%
2/24 • Number of events 2 • From enrolment into study at least 6 days or longer if medically indicated.
|
0.00%
0/24 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/24 • From enrolment into study at least 6 days or longer if medically indicated.
|
12.5%
3/24 • Number of events 3 • From enrolment into study at least 6 days or longer if medically indicated.
|
|
Skin and subcutaneous tissue disorders
Umbilical erythema
|
75.0%
18/24 • Number of events 18 • From enrolment into study at least 6 days or longer if medically indicated.
|
58.3%
14/24 • Number of events 14 • From enrolment into study at least 6 days or longer if medically indicated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60