Phase 4
Completed N=101
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (Part A)
Essential Fatty Acid Deficiency (EFAD)
Source: ClinicalTrials.gov NCT04555044 ↗
Enrolled (actual)
101
Serious AEs
4.0%
Results posted
Dec 2023
Primary outcomePrimary: Number of Participants to Develop Essential Fatty Acid Deficiency (EFAD) Defined by Holman Index > 0.4 — 0; 0 Participants
◆ Published Evidence
Emerging
2citations · ~2 / year
Essential fatty acid deficiency, olive oil-based intravenous lipid emulsion, and genetic polymorphisms: A pediatric randomized controlled trial.
Summary
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.
Linked Publications
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Essential fatty acid deficiency, olive oil-based intravenous lipid emulsion, and genetic polymorphisms: A pediatric randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants to Develop Essential Fatty Acid Deficiency (EFAD) Defined by Holman Index > 0.4 |
0; 0 | — |
| SECONDARY Number of Participants to Develop Parenteral Nutrition-Associated Liver Disease (PNALD) |
1; 2 | — |
| SECONDARY Alkaline Phosphatase (ALP) |
234.0; 187.6; 191.9; 239.7; 405.2; 383.3 | — |
| SECONDARY Aspartate Aminotransferase (AST) |
44.2; 46.3; 45.4; 62.9; 29.0; 37.7 | — |
| SECONDARY Alanine Aminotransferase (ALT) |
7.2; 10.3; 8.7; 6.7; 9.0; 15.3 | — |
| SECONDARY Gamma-Glutamyl Transferase (GGT) |
97.6; 109.5; 150.1; 120.9; 109.3; 97.0 | — |
| SECONDARY Total Bilirubin |
80.065; 81.133; 78.678; 80.877; 86.944; 89.948 | — |
| SECONDARY Direct Bilirubin |
0.237; 0.266; 0.360; 0.357; 0.390; 0.424 | — |
| SECONDARY Stigmasterol Blood Level |
0.80; 1.35; 0.69; 3.85; 0.76; 4.07 | — |
| SECONDARY Campesterol Blood Level |
1.57; 2.52; 1.76; 8.11; 1.89; 8.55 | — |
| SECONDARY Sitosterol Blood Level |
4.51; 8.06; 17.89; 23.40; 20.09; 26.05 | — |
| SECONDARY Cholesterol Blood Level |
2.521; 2.537; 3.019; 2.773; 3.194; 2.799 | — |
| SECONDARY Squalene Blood Level |
0.28; 0.13; 0.50; 0.30; 0.54; 0.30 | — |
| SECONDARY Calories Nutritional Intake |
45.1; 44.1; 42.3; 45.4; 57; 57.4 | — |
| SECONDARY Protein Nutritional Intake |
3.33; 3.20; 2.45; 2.56; 2.78; 2.83 | — |
| SECONDARY Lipid Nutritional Intake |
1.56; 1.84; 1.74; 1.76; 2.48; 2.55 | — |
| SECONDARY Carbohydrates Nutritional Intake |
7.61; 7.47; 6.41; 6.99; 8.52; 8.51 | — |
| SECONDARY Change in Length or Height (and Head Circumference for Infants <1 Year of Age) From Baseline |
13.298; 6.406; 0.918; -0.218 | — |
| SECONDARY Body Weight |
71.429; -100.000 | — |
| SECONDARY Number of Adverse Events of Special Interest |
0; 0.2; 0.4; 0; 0; 0.2 | — |
| SECONDARY Number of Participants With Neonatal Morbidities |
13; 7; 2; 1; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients and/or their legal representative must be able to understand the study and voluntarily sign the informed consent form (ICF) per 21 CFR Part 50.55(e)
- Patients and/or their legal representative accept adherence to protocol requirements
- Patients who are expected to require parenteral nutrition (PN)for at least 7 days
- Premature infants (born at 24 to 400 mg/dL);
- Patients who are unable to tolerate the necessary laboratory monitoring;
- Patients who are enrolled in another clinical trial involving an investigational agent;
- Patients with a known history of either severe hemorrhagic or severe hemolytic disease as judged by the investigator;
- Premature infants born <24 weeks of gestation and patients ≥18 years;
- Premature infants with a birth weight <750 g;
- Patient requires or is expected to require propofol for sedation;
- Patient has received a diagnosis of Coronavirus Disease of 2019 (COVID-19) (diagnosis <2 months prior and/or symptoms have not resolved.
- Newborn patient born to a mother who was diagnosed as COVID-19 positive at delivery or within 2 months prior to delivery
- Female patients who are pregnant. Note: All female patients ≥12 years of age must have a negative urine human chorionic gonadotropin (hCG) pregnancy test at screening. For female patients <12 years of age, a urine hCG test at screening will be performed at the discretion of the investigator based on childbearing potential.
Data sourced from ClinicalTrials.gov (NCT04555044) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.