Phase 4
Completed N=66
The Effect of Lipid Emulsions on Free Fatty Acids and Free Bilirubin in Premature Newborns
Source: ClinicalTrials.gov NCT03857646 ↗Enrolled (actual)
66
Serious AEs
4.6%
Results posted
Mar 2025
Primary outcomePrimary: Free Bilirubin (UB) Serum Levels — 10.5; 9.4 Nanomoles/Liter (nM)
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The goal of this research study is to compare the levels of free fatty acids and free bilirubin between two intravenous lipid emulsion products in premature newborns.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Free Bilirubin (UB) Serum Levels |
10.2; 7.4 | — |
| SECONDARY Unbound Free Fatty Acid (FFAu) Serum Level |
0.105; 0.105 | — |
| SECONDARY Free Fatty Acid (Total) Serum Level |
— | — |
| SECONDARY Number of Participants With Direct Bilirubin >1.8 Milligrams Per Deciliter (mg/dL) |
1; 0 | — |
| SECONDARY Number of Participants With Peak Serum Triglyceride Level >350 mg/dl |
1; 2 | — |
| SECONDARY Mean Serum Triglyceride Level |
153.53; 159.5 | — |
Eligibility Criteria
Inclusion Criteria
- premature newborns ( 28 weeks) 1.5 mg/dl
- with suspected sepsis meeting Systemic inflammatory response syndrome (SIRS) criteria
- undergoing treatment with a continuous infusion of morphine
- with a continuous infusion of pressors (dopamine, dobutamine, epinephrine, etc.)
- positive blood cultures
Data sourced from ClinicalTrials.gov (NCT03857646). 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.