A Phase 2 interventional study of Lipofundin MCT/LCT 20 % and Lipidem 20% in Preterm Infants and Parenteral Nutrition n-3 Fatty Acids, sponsored by B. Braun Melsungen AG. Completed at 2 sites in Germany. Open to participants aged 5 Hours to 3 Days. Per ClinicalTrials.gov, last updated 2021-03-10.
Sponsored by B. Braun Melsungen AG · Phase 2, Interventional, and Prevention
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 48 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →B. Braun Melsungen AG is the lead sponsor of 46 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Lipidem 20 %
Drug: Lipidem 20%
Lipofundin MCT/LCT 20%
Drug: Lipofundin MCT/LCT 20 %
daily i.v. infusion for up to 5 days
daily i.v. infusion for up to 5 days
Safety: Alanine Transaminase (ALT)
Change in ALT between pre/post treatment
Time frame: on Study day -1 & 6
Efficacy: Interleukin-6 (IL-6)
Change of IL-6 Measurement pre/post treatment
Time frame: on Study day -1 & 6
| Milestone | Lipidem 20 % | Lipofundin MCT/LCT 20% |
|---|---|---|
| Started | 24 | 24 |
| Completed | 19 | 18 |
| Not completed | 5 | 6 |
Change in ALT between pre/post treatment
| U/L | MCT:LCT:FO / 5:4:1 | MCT:LCT / 1:1 |
|---|---|---|
| Safety: Alanine Transaminase (ALT) | -0.83 ± 4.61 | -3.27 ± 7.81 |
Change of IL-6 Measurement pre/post treatment
| pg/mL | MCT:LCT:FO / 5:4:1 | MCT:LCT / 1:1 |
|---|---|---|
| Efficacy: Interleukin-6 (IL-6) | -42.23 ± 197.10 | -68.74 ± 101.67 |
Collected over From enrolment into study at least 6 days or longer if medically indicated.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MCT/LCT/FO-containing 20% Fat Emulsion | — | 22/24 (91.7%) | 24/24 (100%) |
| MCT/LCT Emulsion (20%) | — | 19/24 (79.2%) | 24/24 (100%) |
| Event | MCT/LCT/FO-containing 20% Fat Emulsion | MCT/LCT Emulsion (20%) |
|---|---|---|
| Neonatal respiratory distress syndromeRespiratory, thoracic and mediastinal disorders | 15/24 | 14/24 |
| Bronchopulmonary dysplasiaRespiratory, thoracic and mediastinal disorders | 4/24 | 0/24 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 3/24 | 2/24 |
| Amniotic infection syndrome of BlaneInfections and infestations | 2/24 | 0/24 |
| C-reactive protein increasedInvestigations | 2/24 | 2/24 |
| Hemorrhage intracranialNervous system disorders | 1/24 | 2/24 |
| Interleukin level increasedInvestigations | 1/24 | 2/24 |
| Neonatal infectionInfections and infestations | 1/24 | 0/24 |
| Atelectasis neonatalRespiratory, thoracic and mediastinal disorders | 1/24 | 0/24 |
| Bradycardia neonatalCardiac disorders | 1/24 | 0/24 |
| Event | MCT/LCT/FO-containing 20% Fat Emulsion | MCT/LCT Emulsion (20%) |
|---|---|---|
| Blood glucose increasedInvestigations | 24/24 | 22/24 |
| Bradycardia neonatalCardiac disorders | 20/24 | 17/24 |
| Interleukin level increasedInvestigations | 19/24 | 18/24 |
| Umbilical erythemaSkin and subcutaneous tissue disorders | 18/24 | 14/24 |
| Blood lactic acid increasedInvestigations | 15/24 | 16/24 |
| Red blood cell count decreasedInvestigations | 11/24 | 15/24 |
| Reticulocyte count increasedInvestigations | 15/24 | 15/24 |
| Congenital methemoglobinemiaCongenital, familial and genetic disorders | 12/24 | 13/24 |
| Bilirubin conjugated increasedInvestigations | 11/24 | 13/24 |
| Blood triglycerides increasedInvestigations | 5/24 | 8/24 |
| Age, Categorical(Participants) | MCT:LCT:FO / 5:4:1 | MCT:LCT / 1:1 | Total |
|---|---|---|---|
| <=18 years | 24 | 24 | 48 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(hours) | MCT:LCT:FO / 5:4:1 | MCT:LCT / 1:1 | Total |
|---|---|---|---|
| Mean | 12.38 ± 19.38 | 13.74 ± 21.89 | 13.06 ± 20.46 |
| Sex: Female, Male(Participants) | MCT:LCT:FO / 5:4:1 | MCT:LCT / 1:1 | Total |
|---|---|---|---|
| Female | 13 | 13 | 26 |
| Male | 11 | 11 | 22 |
| Region of Enrollment(participants) | MCT:LCT:FO / 5:4:1 | MCT:LCT / 1:1 | Total |
|---|---|---|---|
| Germany | 24 | 24 | 48 |
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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B. Braun Melsungen AG