Phase 4
N=66
The Effect of Lipid Emulsions on Free Fatty Acids and Free Bilirubin in Premature Newborns
Prematurity
Bottom Line
View on ClinicalTrials.gov: NCT03857646 ↗Enrolled (actual)
66
Serious AEs
4.6%
Results posted
Mar 2025
Primary outcome: Primary: Free Bilirubin (UB) Serum Levels — 10.5; 9.4 Nanomoles/Liter (nM)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Intralipid, 20% Intravenous Emulsion (Drug); Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipid (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Free Bilirubin (UB) Serum Levels |
10.2; 7.4 | — |
| PRIMARY Free Bilirubin (UB) Serum Levels |
10.2; 7.4 | — |
| SECONDARY Unbound Free Fatty Acid (FFAu) Serum Level |
0.105; 0.105 | — |
| 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 | — |
| SECONDARY Mean Serum Triglyceride Level |
153.53; 159.5 | — |
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.
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.