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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
101
Lipid injectable emulsion, USP 20%
Standard-of-Care Soybean Oil-Based Lipid Emulsion. 20% (lipid injectable emulsion, USP)
Baxter Investigational Site
Mobile, Alabama, United States
Baxter Investigational Site
New Haven, Connecticut, United States
Baxter Investigational Site
Orlando, Florida, United States
Baxter Investigational Site
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
Time frame: Up to Day 90
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).
Time frame: Up to Day 90
Alkaline Phosphatase (ALP)
Plasma liver function test
Time frame: Up to Day 90
Aspartate Aminotransferase (AST)
Plasma liver function test
Time frame: Up to Day 90
Alanine Aminotransferase (ALT)
Plasma liver function test
Time frame: Up to Day 90
Gamma-Glutamyl Transferase (GGT)
Plasma liver function test
Time frame: Up to Day 90
Total Bilirubin
Plasma liver function test
Time frame: Up to Day 90
Direct Bilirubin
Plasma liver function test
Time frame: Up to Day 90
Stigmasterol Blood Level
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Boston, Massachusetts, United States
Baxter Investigational Site
Jackson, Mississippi, United States
Baxter Investigational Site
Greenville, North Carolina, United States
Baxter Investigational Site
Memphis, Tennessee, United States
Baxter Investigational Site
San Antonio, Texas, United States
Baxter Investigational Site
Provo, Utah, United States
Phytosterol species
Time frame: Up to Day 90
Campesterol Blood Level
Phytosterol species
Time frame: Up to Day 90
Sitosterol Blood Level
Phytosterol species.
Time frame: Up to day 90
Cholesterol Blood Level
Time frame: Up to Day 90
Squalene Blood Level
Time frame: Up to Day 90
Calories Nutritional Intake
Time frame: Up to Day 90
Protein Nutritional Intake
Time frame: Up to Day 90
Lipid Nutritional Intake
Time frame: Up to Day 90
Carbohydrates Nutritional Intake
Time frame: 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) = \[Head circumference (mm) on Day X - Head circumference (mm) at baseline\] / \[X/7\]
Time frame: Up to Day 90
Body Weight
Change in Weight. from baseline (g/kg/day) to EOT for infants \< 1 year of Age
Time frame: Up to day 90
Body Weight
Change in weight from baseline to end of treatment (EOT) for those \> 1 year of age (g/day)
Time frame: Upto Day 90
Number of Adverse Events of Special Interest
Time frame: 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.
Time frame: Up to Day 90