Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Navigate: Correlations HPO
There is one clinical trial.
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.
Description: Determined by Holman Index value >0.4
Measure: Number of participants to develop Essential Fatty Acid Deficiency (EFAD) Time: Up to Day 90Description: Defined by direct bilirubin ≥2 mg/dL when no other etiology for liver dysfunction is present in patients receiving with intravenous lipid emulsion (ILE).
Measure: Number of participants to develop Parenteral Nutrition-Associated Liver Disease (PNALD) Time: Up to Day 90Description: Gain in weight (g/kg/day in infants <1 year of age, g/day in children and adolescents).
Measure: Body Weight Time: Up to Day 90Description: Phytosterol species.
Measure: Stigmasterol Blood Level Time: Up to Day 90Description: Phytosterol species.
Measure: Campesterol Blood Level Time: Up to Day 90Description: Phytosterol species.
Measure: Sitosterol Blood Level Time: Up to Day 90Description: Hepatic Integrity will be assessed by measuring plasma liver function tests.
Measure: Alkaline Phosphatase (ALP) Time: Up to Day 90Description: Hepatic Integrity will be assessed by measuring plasma liver function tests.
Measure: Aspartate Aminotransferase (AST) Time: Up to Day 90Description: Hepatic Integrity will be assessed by measuring plasma liver function tests.
Measure: Alanine Aminotransferase (ALT) Time: Up to Day 90Description: Hepatic Integrity will be assessed by measuring plasma liver function tests.
Measure: Gamma-Glutamyl Transferase (GGT), Time: Up to Day 90Description: Hepatic Integrity will be assessed by measuring plasma liver function tests.
Measure: Total Bilirubin Time: Up to Day 90Description: Will be assessed by measuring plasma liver function tests: alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), and total and direct bilirubin.
Measure: Direct Bilirubin Time: Up to Day 90Description: Intravenous intakes from parenteral nutrition (PN) as well as any intravenous macronutrient additions to the PN solution will be collected and recorded as parenteral intakes. Also enteral/oral nutrition will be collected. For breast milk intake, the macronutrient content will be estimated from volume intakes using mean reference values in mature human milk. Prescribed and actual nutritional intakes.
Measure: Calories nutritional intake Time: Up to Day 90Description: Intravenous intakes from parenteral nutrition (PN) as well as any intravenous macronutrient additions to the PN solution will be collected and recorded as parenteral intakes. Also enteral/oral nutrition will be collected. For breast milk intake, the macronutrient content will be estimated from volume intakes using mean reference values in mature human milk. Prescribed and actual nutritional intakes.
Measure: Protein nutritional intake Time: Up to Day 90Description: Intravenous intakes from parenteral nutrition (PN) as well as any intravenous macronutrient additions to the PN solution will be collected and recorded as parenteral intakes. Also enteral/oral nutrition will be collected. For breast milk intake, the macronutrient content will be estimated from volume intakes using mean reference values in mature human milk. Prescribed and actual nutritional intakes.
Measure: Lipids nutritional intake Time: Up to Day 90Description: Intravenous intakes from parenteral nutrition (PN) as well as any intravenous macronutrient additions to the PN solution will be collected and recorded as parenteral intakes. Also enteral/oral nutrition will be collected. For breast milk intake, the macronutrient content will be estimated from volume intakes using mean reference values in mature human milk. Prescribed and actual nutritional intakes
Measure: Carbohydrates nutritional intake Time: Up to Day 90Description: The AE rate per 100 patient days will be reported for the overall study period, and may be stratified into Weeks 1, 2, 3, and 4 as appropriate.
Measure: Adverse Events (AE) Rate per 100 patient days Time: Up to Day 120 (30 Days After Subject's Last Study Treatment if hospital discharge has not occurred)Description: Gain in length/height (mm/week in all) and head circumference (mm/week in infants <1 year).
Measure: Length or height (and head circumference for infants <1 year of age) Time: Up to Day 90Description: Includes bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP), intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), necrotizing enterocolitis (NEC), and late-onset sepsis in enrolled premature infants born <37 weeks of gestation.
Measure: Number of Participants with Neonatal morbidities Time: Up to Day 90Description: Will include known AE's related to parenteral nutrition (PN) with intravenous lipid emulsion (ILE).
Measure: Adverse Event's of Special Interest Time: Up to Day 120 (30 Days After Subject's Last Study Treatment if hospital discharge has not occurred)Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports