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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Lipidem 20 % |
|
| 2 | Active Comparator | Lipofundin MCT/LCT 20% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipofundin MCT/LCT 20 % | Drug | daily i.v. infusion for up to 5 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Alanine Transaminase (ALT) | Change in ALT between pre/post treatment | on Study day -1 & 6 |
| Efficacy: Interleukin-6 (IL-6) | Change of IL-6 Measurement pre/post treatment | on Study day -1 & 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Berthold V. Koletzko, Prof., MD | Dr. von Hauner Children´s Hospital, University of Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatology of the Pediatric University Hospital | Munich | Bavaria | 80337 | Germany | ||
| Ernst Moritz Arndt University , Childrens Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lipidem 20 % | Lipidem 20 % Lipidem 20%: daily i.v. infusion for up to 5 days |
| FG001 | Lipofundin MCT/LCT 20% | Lipofundin MCT/LCT 20% Lipofundin MCT/LCT 20 %: daily i.v. infusion for up to 5 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MCT:LCT:FO / 5:4:1 | Lipidem 20%: daily i.v. infusion for up to 5 days |
| BG001 | MCT:LCT / 1:1 | Lipofundin MCT/LCT 20 %: daily i.v. infusion for up to 5 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety: Alanine Transaminase (ALT) | Change in ALT between pre/post treatment | 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. | Posted | Mean | Standard Deviation | U/L | on Study day -1 & 6 |
|
From enrolment into study at least 6 days or longer if medically indicated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MCT/LCT/FO-containing 20% Fat Emulsion | Preterm infants received a study treatment by parenteral route with MCT/LCT/FO Lipidem 20%: daily i.v. infusion for up to 6 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia neonatal | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study manager | B.Braun Melsungen AG | +49 5661 71 | 0 | studies@bbraun.com |
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| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
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| Lipidem 20% |
| Drug |
daily i.v. infusion for up to 5 days |
|
| Greifswald |
| 17487 |
| Germany |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | hours |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Efficacy: Interleukin-6 (IL-6) | Change of IL-6 Measurement pre/post treatment | Per protocol population | Posted | Mean | Standard Deviation | pg/mL | on Study day -1 & 6 |
|
|
|
|
| 22 |
| 24 |
| 24 |
| 24 |
| EG001 | MCT/LCT Emulsion (20%) | 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 | 19 | 24 | 24 | 24 |
| Neonatal infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Amniotic infection syndrome of Blane | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Atelectasis neonatal | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Bradycardia neonatal | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood glucose decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Hemorrhage intracranial | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Interleukin level increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Neonatal respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Patent ductus arteriosus | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Congenital pneumonia | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Neonatal respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Systemic inflammatory response syndrome | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Ureaplasma infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Sepsis neonatal | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Ileal stenosis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Congenital inguinal hernia | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Escherichia sepsis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Necrotising enterocolitis neonatal | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Bradycardia neonatal | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Congenital methemoglobinemia | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hematemesis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Infusion site erythema | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Amniotic infection syndrome of Blane | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Escherichia infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Skin injury | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Base excess increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Bilirubin conjugated increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood lactic acid increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Hemoglobin decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Interleukin level increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Prothrombin level decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Prothrombin level increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Reticulocyte count increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| White blood cell analysis decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| White blood cell analysis increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Infantile apnoeic attack | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Neonatal respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Respiratory disorder neonatal | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Umbilical erythema | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
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| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |