Phase 4
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)
Bottom Line
View on ClinicalTrials.gov: NCT04555044 ↗Enrolled (actual)
101
Serious AEs
4.0%
Results posted
Dec 2023
Primary outcome: Primary: Number of Participants to Develop Essential Fatty Acid Deficiency (EFAD) Defined by Holman Index > 0.4 — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Clinolipid (Drug); Intralipid (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Baxter Healthcare Corporation
- Primary completion
- Oct 2022
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 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 | — |
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.
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). 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.