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This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care (Intralipid) from 7 up to 90 days to develop Essential Fatty Acid Deficiency (EFAD). Additionally, this study design will evaluate the safety and efficacy of using Clinolipid or Intralipid in a pediatric population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinolipid | Experimental | Dosing based on American Academy of Pediatrics (AAP), American Academy Society for Parenteral and Enteral Nutrition (ASPEN), European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN)/ European Society for Parenteral and Enteral Nutrition (ESPEN)/ European Society of Paediatric Research (ESPR)/ Chinese Society for Parenteral and Enteral Nutrition (CSPEN) guidelines. Study treatment will be administered intravenously in the hospital setting from 7 up to 90 days using either a syringe pump or an infusion pump as appropriate for the daily volume of infusate. The flow rate will be prescribed by the Investigator to provide the daily dosage over 20 to 24 hours. |
|
| Intralipid | Active Comparator | Dosing based on AAP, ASPEN, ESPGHAN/ESPEN/ESPR/CSPEN guidelines. Study treatment will be administered intravenously in the hospital setting from 7 up to 90 days using either a syringe pump or an infusion pump as appropriate for the daily volume of infusate. The flow rate will be prescribed by the Investigator to provide the daily dosage over 20 to 24 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinolipid | Drug | Lipid injectable emulsion, USP 20% |
| |
| Intralipid |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants to Develop Essential Fatty Acid Deficiency (EFAD) Defined by Holman Index > 0.4 | Holman Index is the plasma Triene:Tetraene ratio, specifically 5,8,11-eicosatrienoic acid [mead acid] to 5,8,11,14 eicosatetraenoic acid [arachidonic acid, [ARA] ratio](streamdown:incomplete-link) | Up to Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants to Develop Parenteral Nutrition-Associated Liver Disease (PNALD) | Defined by direct bilirubin ≥2 mg/dL in patients receiving with intravenous lipid emulsion (ILE). | Up to Day 90 |
| Alkaline Phosphatase (ALP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Baxter Healthcare Corporation | Baxter Healthcare Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baxter Investigational Site | Mobile | Alabama | 36604 | United States | ||
| Baxter Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40415417 | Derived | Blanco C, Chang W, Bhatt AJ, Gerday E, Talati AJ, Dereddy N, Singh R, Ryan E, Senterre T. Essential fatty acid deficiency, olive oil-based intravenous lipid emulsion, and genetic polymorphisms: A pediatric randomized controlled trial. J Pediatr Gastroenterol Nutr. 2025 Aug;81(2):314-323. doi: 10.1002/jpn3.70072. Epub 2025 May 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clinolipid (Lipid Injectable Emulsion) 20% | Clinolipid was administered intravenously in the hospital setting from 7 up to 90 days using either a syringe pump or an infusion pump as appropriate for the daily volume of infusate. The flow rate was prescribed by the Investigator to provide the daily dosage (based on general pediatric PN guidelines) over 20 to 24 hours and ensure that the maximum lipid infusion rate did not exceed 0.15 g/kg/hour. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 22, 2022 | Sep 7, 2023 |
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| Drug |
Standard-of-Care Soybean Oil-Based Lipid Emulsion. 20% (lipid injectable emulsion, USP) |
|
Plasma liver function test
| Up to Day 90 |
| Aspartate Aminotransferase (AST) | Plasma liver function test | Up to Day 90 |
| Alanine Aminotransferase (ALT) | Plasma liver function test | Up to Day 90 |
| Gamma-Glutamyl Transferase (GGT) | Plasma liver function test | Up to Day 90 |
| Total Bilirubin | Plasma liver function test | Up to Day 90 |
| Direct Bilirubin | Plasma liver function test | Up to Day 90 |
| Stigmasterol Blood Level | Phytosterol species | Up to Day 90 |
| Campesterol Blood Level | Phytosterol species | Up to Day 90 |
| Sitosterol Blood Level | Phytosterol species. | Up to day 90 |
| Cholesterol Blood Level | Up to Day 90 |
| Squalene Blood Level | Up to Day 90 |
| Calories Nutritional Intake | Up to Day 90 |
| Protein Nutritional Intake | Up to Day 90 |
| Lipid Nutritional Intake | Up to Day 90 |
| Carbohydrates Nutritional Intake | Up to Day 90 |
| Change in Length or Height (and Head Circumference for Infants <1 Year of Age) From Baseline | Change in length/height from baseline (mm/week in all) = [Length (mm) on Day X - Length (mm) at baseline] / [X/7] Change in head circumference from baseline (mm/week in infants <1 year) = [Head circumference (mm) on Day X - Head circumference (mm) at baseline] / [X/7] | Up to Day 90 |
| Body Weight | Change in Weight. from baseline (g/kg/day) to EOT for infants < 1 year of Age | Up to day 90 |
| Body Weight | Change in weight from baseline to end of treatment (EOT) for those > 1 year of age (g/day) | Upto Day 90 |
| Number of Adverse Events of Special Interest | Up to Day 120 (30 Days After Subject's Last Study Treatment if hospital discharge has not occurred) |
| Number of Participants With Neonatal Morbidities | Neonatal Morbidities are presented for premature infants born < 37 weeks of gestation up to 1 month corrected age. Patients may have more than 1 neonatal morbidity. | Up to Day 90 |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| Baxter Investigational Site | Orlando | Florida | 32803 | United States |
| Baxter Investigational Site | Boston | Massachusetts | 09111 | United States |
| Baxter Investigational Site | Jackson | Mississippi | 39216 | United States |
| Baxter Investigational Site | Greenville | North Carolina | 27834 | United States |
| Baxter Investigational Site | Memphis | Tennessee | 38163 | United States |
| Baxter Investigational Site | San Antonio | Texas | 78229 | United States |
| Baxter Investigational Site | Provo | Utah | 84604 | United States |
| FG001 | Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Intralipid was administered intravenously in the hospital setting from 7 up to 90 days using either a syringe pump or an infusion pump as appropriate for the daily volume of infusate. The flow rate was prescribed by the Investigator to provide the daily dosage (based on general pediatric PN guidelines) over 20 to 24 hours and ensure that the maximum lipid infusion rate did not exceed 0.15 g/kg/hour. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat population: all patients who were randomized to receive either Clinolipid or standard-of-care soybean oil-based lipid emulsion (Intralipid)
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| ID | Title | Description |
|---|---|---|
| BG000 | Clinolipid (Lipid Injectable Emulsion) 20% | Clinolipid was administered intravenously in the hospital setting from 7 up to 90 days using either a syringe pump or an infusion pump as appropriate for the daily volume of infusate. The flow rate was prescribed by the Investigator to provide the daily dosage (based on general pediatric PN guidelines) over 20 to 24 hours and ensure that the maximum lipid infusion rate did not exceed 0.15 g/kg/hour. |
| BG001 | Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Intralipid was administered intravenously in the hospital setting from 7 up to 90 days using either a syringe pump or an infusion pump as appropriate for the daily volume of infusate. The flow rate was prescribed by the Investigator to provide the daily dosage (based on general pediatric PN guidelines) over 20 to 24 hours and ensure that the maximum lipid infusion rate did not exceed 0.15 g/kg/hour. |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Weight at birth | Intent-to-treat population: all patients who were randomized to receive either Clinolipid or standard-of-care soybean oil-based lipid emulsion (Intralipid) | Count of Participants | Participants |
| |||||||||||||||||
| Diagnosis for PN (NOTE: Multiple diagnoses for PN are allowed, so n may be greater than number of su | Number | 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 | Number of Participants to Develop Essential Fatty Acid Deficiency (EFAD) Defined by Holman Index > 0.4 | Holman Index is the plasma Triene:Tetraene ratio, specifically 5,8,11-eicosatrienoic acid [mead acid] to 5,8,11,14 eicosatetraenoic acid [arachidonic acid, [ARA] ratio](streamdown:incomplete-link) | Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment. Per protocol set: all patients in the FAS who have Holman Index measurements taken at baseline and at least 1 other timepoint post-baseline, who have received a minimum of 7 days of ILE treatment, and are without a major protocol violation (i.e., violation that potentially impacts the primary endpoint). | Posted | Count of Participants | Participants | Up to Day 90 |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants to Develop Parenteral Nutrition-Associated Liver Disease (PNALD) | Defined by direct bilirubin ≥2 mg/dL in patients receiving with intravenous lipid emulsion (ILE). | Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment. | Posted | Count of Participants | Participants | Up to Day 90 |
| |||||||||||||||||||||||||||||||
| Secondary | Alkaline Phosphatase (ALP) | Plasma liver function test | Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment. | Posted | Mean | Standard Deviation | IU/L | Up to Day 90 |
| ||||||||||||||||||||||||||||||
| Secondary | Aspartate Aminotransferase (AST) | Plasma liver function test | Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment. | Posted | Mean | Standard Deviation | IU/L | Up to Day 90 |
| ||||||||||||||||||||||||||||||
| Secondary | Alanine Aminotransferase (ALT) | Plasma liver function test | Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment. | Posted | Mean | Standard Deviation | IU/L | Up to Day 90 |
| ||||||||||||||||||||||||||||||
| Secondary | Gamma-Glutamyl Transferase (GGT) | Plasma liver function test | Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment. | Posted | Mean | Standard Deviation | IU/L | Up to Day 90 |
| ||||||||||||||||||||||||||||||
| Secondary | Total Bilirubin | Plasma liver function test | Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment. | Posted | Mean | Standard Deviation | umol/L | Up to Day 90 |
| ||||||||||||||||||||||||||||||
| Secondary | Direct Bilirubin | Plasma liver function test | Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment. | Posted | Mean | Standard Deviation | mg/dL | Up to Day 90 |
| ||||||||||||||||||||||||||||||
| Secondary | Stigmasterol Blood Level | Phytosterol species | Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment. | Posted | Mean | Standard Deviation | mg/L | Up to Day 90 |
| ||||||||||||||||||||||||||||||
| Secondary | Campesterol Blood Level | Phytosterol species | Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment. | Posted | Mean | Standard Deviation | mg/dL | Up to Day 90 |
| ||||||||||||||||||||||||||||||
| Secondary | Sitosterol Blood Level | Phytosterol species. | Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment. | Posted | Mean | Standard Deviation | mg/L | Up to day 90 |
| ||||||||||||||||||||||||||||||
| Secondary | Cholesterol Blood Level | Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment. | Posted | Mean | Standard Deviation | mmol/L | Up to Day 90 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Squalene Blood Level | Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment. | Posted | Mean | Standard Deviation | mg/L | Up to Day 90 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Calories Nutritional Intake | Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment. | Posted | Mean | Standard Deviation | kCal/kg/24 hours | Up to Day 90 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Protein Nutritional Intake | Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment. | Posted | Mean | Standard Deviation | g/kg/24hours | Up to Day 90 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Lipid Nutritional Intake | Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment. | Posted | Mean | Standard Deviation | g/kg/24 hours | Up to Day 90 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Carbohydrates Nutritional Intake | Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment. | Posted | Mean | Standard Deviation | g/kg/24 hours | Up to Day 90 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change in Length or Height (and Head Circumference for Infants <1 Year of Age) From Baseline | Change in length/height from baseline (mm/week in all) = [Length (mm) on Day X - Length (mm) at baseline] / [X/7] Change in head circumference from baseline (mm/week in infants <1 year) = [Head circumference (mm) on Day X - Head circumference (mm) at baseline] / [X/7] | Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment. | Posted | Mean | Standard Deviation | mm/week | Up to Day 90 |
| ||||||||||||||||||||||||||||||
| Secondary | Body Weight | Change in Weight. from baseline (g/kg/day) to EOT for infants < 1 year of Age | Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment. | Posted | Mean | Standard Deviation | g/kg/day | Up to day 90 |
| ||||||||||||||||||||||||||||||
| Secondary | Body Weight | Change in weight from baseline to end of treatment (EOT) for those > 1 year of age (g/day) | Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment. | Posted | Mean | Standard Deviation | g/day | Upto Day 90 |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Adverse Events of Special Interest | Safety analysis set (SS): the set of all patients who have been administered study treatment (Clinolipid or Intralipid). Patients will be analyzed according to treatment received. | Posted | Number | Number of Events per 100 Patient Days | Up to Day 120 (30 Days After Subject's Last Study Treatment if hospital discharge has not occurred) |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Neonatal Morbidities | Neonatal Morbidities are presented for premature infants born < 37 weeks of gestation up to 1 month corrected age. Patients may have more than 1 neonatal morbidity. | Posted | Count of Participants | Participants | Up to Day 90 |
|
|
Up to day 120
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clinolipid (Lipid Injectable Emulsion) 20% | Clinolipid was administered intravenously in the hospital setting from 7 up to 90 days using either a syringe pump or an infusion pump as appropriate for the daily volume of infusate. The flow rate was prescribed by the Investigator to provide the daily dosage (based on general pediatric PN guidelines) over 20 to 24 hours and ensure that the maximum lipid infusion rate did not exceed 0.15 g/kg/hour. | 1 | 50 | 2 | 50 | 40 | 50 |
| EG001 | Intralipid (SOC Soybean Oil-based Lipid Emulsion) | Intralipid was administered intravenously in the hospital setting from 7 up to 90 days using either a syringe pump or an infusion pump as appropriate for the daily volume of infusate. The flow rate was prescribed by the Investigator to provide the daily dosage (based on general pediatric PN guidelines) over 20 to 24 hours and ensure that the maximum lipid infusion rate did not exceed 0.15 g/kg/hour. | 0 | 51 | 2 | 51 | 39 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PNEUMOPERITONEUM | Gastrointestinal disorders | Systematic Assessment |
| ||
| HYPOXIC-ISCHAEMIC ENCEPHALOPATHY | Nervous system disorders | Systematic Assessment |
| ||
| INTRAVENTRICULAR HAEMORRHAGE NEONATAL | Nervous system disorders | Systematic Assessment |
| ||
| SEIZURE | Nervous system disorders | Systematic Assessment |
| ||
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA NEONATAL | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| COAGULATION FACTOR DEFICIENCY | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| PANCYTOPENIA | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| BRADYCARDIA NEONATAL | Cardiac disorders | Systematic Assessment |
| ||
| CARDIAC DYSFUNCTION | Cardiac disorders | Systematic Assessment |
| ||
| VENTRICULAR TACHYCARDIA | Cardiac disorders | Systematic Assessment |
| ||
| ADRENAL INSUFFICIENCY NEONATAL | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| ANKYLOGLOSSIA CONGENITAL | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| ATRIAL SEPTAL DEFECT | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| HYDROCELE | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| NEWBORN PERSISTENT PULMONARY HYPERTENSION | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| PATENT DUCTUS ARTERIOSUS | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| PHYTOSTEROLAEMIA | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| PSEUDOHYPOALDOSTERONISM | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| HYPOTHYROIDISM | Endocrine disorders | Systematic Assessment |
| ||
| EYE DISCHARGE | Eye disorders | Systematic Assessment |
| ||
| ABDOMINAL DISTENSION | Gastrointestinal disorders | Systematic Assessment |
| ||
| ANAL FISSURE | Gastrointestinal disorders | Systematic Assessment |
| ||
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | Systematic Assessment |
| ||
| HAEMATOCHEZIA | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ileus | Gastrointestinal disorders | Systematic Assessment |
| ||
| INTESTINAL DILATATION | Gastrointestinal disorders | Systematic Assessment |
| ||
| MECONIUM PLUG SYNDROME | Gastrointestinal disorders | Systematic Assessment |
| ||
| NECROTISING ENTEROCOLITIS NEONATAL | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| ADMINISTRATION SITE EXTRAVASATION | General disorders | Systematic Assessment |
| ||
| CATHETER SITE ULCER | General disorders | Systematic Assessment |
| ||
| INFUSION SITE EXTRAVASATION | General disorders | Systematic Assessment |
| ||
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | Systematic Assessment |
| ||
| HYPERBILIRUBINAEMIA NEONATAL | Hepatobiliary disorders | Systematic Assessment |
| ||
| CONJUNCTIVITIS | Infections and infestations | Systematic Assessment |
| ||
| EYE INFECTION | Infections and infestations | Systematic Assessment |
| ||
| PUSTULE | Infections and infestations | Systematic Assessment |
| ||
| RESPIRATORY TRACT INFECTION VIRAL | Infections and infestations | Systematic Assessment |
| ||
| SEPSIS NEONATAL | Infections and infestations | Systematic Assessment |
| ||
| SKIN INFECTION | Infections and infestations | Systematic Assessment |
| ||
| STREPTOCOCCAL SEPSIS | Infections and infestations | Systematic Assessment |
| ||
| TRACHEITIS | Infections and infestations | Systematic Assessment |
| ||
| URINARY TRACT INFECTION | Infections and infestations | Systematic Assessment |
| ||
| URINARY TRACT INFECTION FUNGAL | Infections and infestations | Systematic Assessment |
| ||
| URINARY TRACT INFECTION NEONATAL | Infections and infestations | Systematic Assessment |
| ||
| WOUND INFECTION | Infections and infestations | Systematic Assessment |
| ||
| POSTOPERATIVE RESPIRATORY FAILURE | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| SKIN ABRASION | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | Systematic Assessment |
| ||
| BLOOD TRIGLYCERIDES INCREASED | Investigations | Systematic Assessment |
| ||
| CARDIOVASCULAR EXAMINATION ABNORMAL | Investigations | Systematic Assessment |
| ||
| FREE FATTY ACIDS DECREASED | Investigations | Systematic Assessment |
| ||
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | Systematic Assessment |
| ||
| GASTRIC FLUID ANALYSIS ABNORMAL | Investigations | Systematic Assessment |
| ||
| PHYTOSTEROL LEVEL INCREASED | Investigations | Systematic Assessment |
| ||
| TRANSAMINASES INCREASED | Investigations | Systematic Assessment |
| ||
| FAILURE TO THRIVE | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| FEEDING INTOLERANCE | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| HYPERCHLORAEMIA | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| HYPERMAGNESAEMIA | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| HYPERNATRAEMIA | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| HYPOVOLAEMIA | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| METABOLIC ACIDOSIS | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| NEONATAL HYPONATRAEMIA | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| OSTEOPENIA | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| HAEMANGIOMA OF SKIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| HYDROCEPHALUS | Nervous system disorders | Systematic Assessment |
| ||
| INTRAVENTRICULAR HAEMORRHAGE | Nervous system disorders | Systematic Assessment |
| ||
| INTRAVENTRICULAR HAEMORRHAGE NEONATAL | Nervous system disorders | Systematic Assessment |
| ||
| RENAL INJURY | Renal and urinary disorders | Systematic Assessment |
| ||
| BRONCHOPULMONARY DYSPLASIA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| INFANTILE APNOEA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| NEONATAL RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| NEONATAL RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| STRIDOR | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| DERMATITIS DIAPER | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| RASH | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| RASH ERYTHEMATOUS | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| RASH PAPULAR | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| SKIN DISORDER | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
The Sponsor reserves the right of prior review and approval of data from this study relative to the potential release of proprietary information to any publication or for any presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Name/Official Title: Baxter Clinical Trials Disclosure Call Center | Organization: Baxter Healthcare | (224) 948-7359 | Global_CORP_ClinicalTrialsDisclosure@baxter.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 30, 2023 | Sep 7, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| C536647 | Pena Shokeir syndrome, type 1 |
| D012778 | Short Bowel Syndrome |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| C545823 | soybean oil, phospholipid emulsion |
Not provided
Not provided
Not provided
| >=65 years |
|
| Full Term Neonate (=37 weeks to <1 month) |
|
| Child (1 to <10 years) |
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| Adolescent (10 to <18 years) |
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| Male |
|
| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| Low (1500-2499 g) |
|
| Very Low (1000-1499 g) |
|
| Extremely Low (< 1000 g) |
|
| NA ( Child or Adolescent) |
|
| Gastroschisis |
|
| Enteropathies including inflammatory gastrointestinal diseases |
|
| Feeding Intolerance |
|
| Meconium ileus |
|
| Necrotizing enterocolitis |
|
| Persistent pulmonary hypertension |
|
| Premature infant with feeding intolerance |
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| Premature infant with gastroschisis |
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| Sepsis |
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| Short bowel syndrome |
|
| Small for gestational age |
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