Parenteral Nutrition n-3 Fatty Acids, Preterm Infants
Conditions
Keywords
n-3 Polyunsaturated Fatty Acids (PUFA), parenteral nutrition, preterm infant
Brief summary
The study shall provide evidence for the save and efficient use of a fish oil containing lipid emulsion in parenteral nutrition of preterm infants.Safety will be assessed by monitoring hepatological and hematological laboratory parameters. Efficiency will be assessed by monitoring of inflammatory parameters.
Interventions
DRUGLipofundin MCT/LCT 20 %
daily i.v. infusion for up to 5 days
DRUGLipidem 20%
daily i.v. infusion for up to 5 days
Sponsors
B. Braun Melsungen AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Hours to 3 Days
Healthy volunteers
No
Inclusion criteria
* prematurity (birth weight 500 - 1500 g) * postnatal age \<= 72 h * need for cumulative parenteral energy supply of at least 70% during study duration * signed informed consent form
Exclusion criteria
* simultaneous participation in another clinical study * platelet count below 50000 /ml * cumulative enteral energy supply of \> 30 % during study duration * serious congenital infections and/or diseases * serious metabolic disturbances * severe cranial bleeding (Papile III, IV) * need for administration of blood products * contra-indication for iv lipid administration * withdrawal of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Alanine Transaminase (ALT) | on Study day -1 & 6 | Change in ALT between pre/post treatment |
| Efficacy: Interleukin-6 (IL-6) | on Study day -1 & 6 | Change of IL-6 Measurement pre/post treatment |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MCT:LCT:FO / 5:4:1 Lipidem 20%: daily i.v. infusion for up to 5 days | 24 |
| MCT:LCT / 1:1 Lipofundin MCT/LCT 20 %: daily i.v. infusion for up to 5 days | 24 |
| Total | 48 |
Baseline characteristics
| Characteristic | MCT:LCT / 1:1 | MCT:LCT:FO / 5:4:1 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 24 Participants | 24 Participants | 48 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 13.74 hours STANDARD_DEVIATION 21.89 | 12.38 hours STANDARD_DEVIATION 19.38 | 13.06 hours STANDARD_DEVIATION 20.46 |
| Region of Enrollment Germany | 24 participants | 24 participants | 48 participants |
| Sex: Female, Male Female | 13 Participants | 13 Participants | 26 Participants |
| Sex: Female, Male Male | 11 Participants | 11 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 24 / 24 | 24 / 24 |
| serious Total, serious adverse events | 22 / 24 | 19 / 24 |
Outcome results
Primary
Efficacy: Interleukin-6 (IL-6)
Change of IL-6 Measurement pre/post treatment
Time frame: on Study day -1 & 6
Population: Per protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MCT:LCT:FO / 5:4:1 | Efficacy: Interleukin-6 (IL-6) | -42.23 pg/mL | Standard Deviation 197.1 |
| MCT:LCT / 1:1 | Efficacy: Interleukin-6 (IL-6) | -68.74 pg/mL | Standard Deviation 101.67 |
p-value: 0.0264Wilcoxon (Mann-Whitney)
Primary
Safety: Alanine Transaminase (ALT)
Change in ALT between pre/post treatment
Time frame: on Study day -1 & 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MCT:LCT:FO / 5:4:1 | Safety: Alanine Transaminase (ALT) | -0.83 U/L | Standard Deviation 4.61 |
| MCT:LCT / 1:1 | Safety: Alanine Transaminase (ALT) | -3.27 U/L | Standard Deviation 7.81 |
p-value: 0.3654Wilcoxon (Mann-Whitney)