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The Effect of Lipid Emulsions on Free Fatty Acids and Free Bilirubin in Premature Newborns

The Effect of Lipid Emulsions on Free Fatty Acids and Free Bilirubin in Premature Newborns

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03857646
Enrollment
66
Registered
2019-02-28
Start date
2019-03-02
Completion date
2020-06-11
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity

Keywords

parenteral nutrition, lipid emulsion, free bilirubin, free fatty acids

Brief 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.

Interventions

Lipids start at 1 g/kg/day and advance by 1 g/kg/day to a maximum of 3 g/kg/day as tolerated by the the neonate.

DRUGSoybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipid

Lipids start at 1 g/kg/day and advance by 1 g/kg/day to a maximum of 3 g/kg/day as tolerated by the the neonate.

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
0 Days to 8 Days
Healthy volunteers
No

Inclusion criteria

* premature newborns (\<32 weeks gestation, stratified \<28 weeks versus \>28 weeks) \<8 days of age * receiving lipid infusions \<1 g/kg/day at enrollment * anticipated to be treated with 3 g/kg/day for a minimum of 48 hours.

Exclusion criteria

* patients with direct hyperbilirubinemia \>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

Design outcomes

Primary

MeasureTime frame
Free Bilirubin (UB) Serum Levelsfirst day of infusion at 3 g/kg/day

Secondary

MeasureTime frameDescription
Mean Serum Triglyceride Levelfirst day of infusion at 3 g/kg/day
Number of Participants With Peak Serum Triglyceride Level >350 mg/dlfirst or second days of infusion at 3 g/kg/day
Unbound Free Fatty Acid (FFAu) Serum Levelfirst day of infusion at 3 g/kg/dayTo measure unbound free fatty acid level, a fluorescent probe called Acrylodan-Labeled Intestinal Fatty Acid Binding Protein 2 (ADIFAB2) was used. The ADIFAB2 fluorescent probe is a fatty acid binding protein complexed with a fluorescent group. Once mixed with a sample, the ADIFAB2 fluorescent probe binds all unbound free fatty acid in the sample; therefore, measurement of fluorescence indicates the amount of unbound free fatty acid in the sample. After binding of the ADIFAB2 fluorescent probe to the sample, fluorescence intensities are measured at two wavelengths (550 nanometers and 457 nanometers), and for this outcome measure the R value is reported. The R value is the ratio of the fluorescence intensity at 550 nanometers to the fluorescence intensity at 457 nanometers.
Free Fatty Acid (Total) Serum Levelsecond day of infusion at 3 g/kg/day
Number of Participants With Direct Bilirubin >1.8 Milligrams Per Deciliter (mg/dL)first and/or second days of infusion at 3 g/kg/day

Countries

United States

Participant flow

Participants by arm

ArmCount
Intralipid
Intralipid, 20% Intravenous Emulsion: Lipids start at 1 g/kg/day and advance by 1 g/kg/day to a maximum of 3 g/kg/day as tolerated by the the neonate.
33
SMOF Lipid
SMOF lipid: Lipids start at 1 g/kg/day and advance by 1 g/kg/day to a maximum of 3 g/kg/day as tolerated by the the neonate.
33
Total66

Baseline characteristics

CharacteristicIntralipidSMOF LipidTotal
Age, Continuous1.81 days
STANDARD_DEVIATION 0.53
1.83 days
STANDARD_DEVIATION 0.37
1.82 days
STANDARD_DEVIATION 0.45
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
18 Participants18 Participants36 Participants
Sex: Female, Male
Male
15 Participants15 Participants30 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
2 / 331 / 33
other
Total, other adverse events
0 / 331 / 33
serious
Total, serious adverse events
2 / 331 / 33

Outcome results

Primary

Free Bilirubin (UB) Serum Levels

Time frame: first day of infusion at 3 g/kg/day

Population: UB levels were measured in 2/3 of the samples before the pandemic closed the analytic laboratory, and the other 1/3 were assessed post-pandemic 1.5 years later. The UB data are invalid due to an issue associated with the delay, that is, the UB measurement device developed by the bench scientist colleagues was recalibrated in the interim such that the UB results pre vs post recalibration are incomparable.~Data were not collected for 1 participant in the Intralipid arm.

ArmMeasureValue (MEAN)Dispersion
IntralipidFree Bilirubin (UB) Serum Levels10.5 Nanomoles/Liter (nM)Standard Deviation 7.5
SMOF LipidFree Bilirubin (UB) Serum Levels9.4 Nanomoles/Liter (nM)Standard Deviation 7
Primary

Free Bilirubin (UB) Serum Levels

Time frame: second day of infusion at 3 g/kg/day

Population: UB levels were measured in 2/3 of the samples before the pandemic closed the analytic laboratory, and the other 1/3 were assessed post-pandemic 1.5 years later. The UB data are invalid due to an issue associated with the delay, that is, the UB measurement device developed by the bench scientist colleagues was recalibrated in the interim such that the UB results pre vs post recalibration are incomparable.

ArmMeasureValue (MEAN)Dispersion
IntralipidFree Bilirubin (UB) Serum Levels10.2 Nanomoles/Liter (nM)Standard Deviation 7.8
SMOF LipidFree Bilirubin (UB) Serum Levels7.4 Nanomoles/Liter (nM)Standard Deviation 2.2
Secondary

Free Fatty Acid (Total) Serum Level

Time frame: second day of infusion at 3 g/kg/day

Population: Data were not collected for this outcome measure.

Secondary

Mean Serum Triglyceride Level

Time frame: first day of infusion at 3 g/kg/day

Population: Of those who had infusion of 3 g/kg/day on the first day, data were not collected for 1 participant in the Intralipid arm, and data were not collected for 2 participants in the SMOF lipid arm.

ArmMeasureValue (MEAN)Dispersion
IntralipidMean Serum Triglyceride Level177.23 milligrams per deciliter (mg/dL)Standard Deviation 91.73
SMOF LipidMean Serum Triglyceride Level139.37 milligrams per deciliter (mg/dL)Standard Deviation 74.63
Secondary

Mean Serum Triglyceride Level

Time frame: second day of infusion at 3 g/kg/day

Population: Of those who had infusion of 3 g/kg/day for two days, data were not collected for 14 participants in the Intralipid arm, and data were not collected for 13 participants in the SMOF arm.

ArmMeasureValue (MEAN)Dispersion
IntralipidMean Serum Triglyceride Level153.53 milligrams per deciliter (mg/dL)Standard Deviation 63.84
SMOF LipidMean Serum Triglyceride Level159.5 milligrams per deciliter (mg/dL)Standard Deviation 120.23
Secondary

Number of Participants With Direct Bilirubin >1.8 Milligrams Per Deciliter (mg/dL)

Time frame: first and/or second days of infusion at 3 g/kg/day

Population: Data are reported for all who had 1 or 2 days of infusion of 3 g/kg/day.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
IntralipidNumber of Participants With Direct Bilirubin >1.8 Milligrams Per Deciliter (mg/dL)1 Participants
SMOF LipidNumber of Participants With Direct Bilirubin >1.8 Milligrams Per Deciliter (mg/dL)0 Participants
Secondary

Number of Participants With Peak Serum Triglyceride Level >350 mg/dl

Time frame: first or second days of infusion at 3 g/kg/day

Population: Of those who had 1 or 2 days of infusion of 3 g/kg/day, data were not collected for 1 participant in the Intralipid arm, and data were not collected for 2 participants in the SMOF lipid arm.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
IntralipidNumber of Participants With Peak Serum Triglyceride Level >350 mg/dl1 Participants
SMOF LipidNumber of Participants With Peak Serum Triglyceride Level >350 mg/dl2 Participants
Secondary

Unbound Free Fatty Acid (FFAu) Serum Level

To measure unbound free fatty acid level, a fluorescent probe called ADIFAB2 was used. The ADIFAB2 fluorescent probe is a fatty acid binding protein complexed with a fluorescent group. Once mixed with a sample, the ADIFAB2 fluorescent probe binds all unbound free fatty acid in the sample; therefore, measurement of fluorescence indicates the amount of unbound free fatty acid in the sample. After binding of the ADIFAB2 fluorescent probe to the sample, fluorescence intensities are measured at two wavelengths (550 nanometers and 457 nanometers), and for this outcome measure the R value is reported. The R value is the ratio of the fluorescence intensity at 550 nanometers to the fluorescence intensity at 457 nanometers.

Time frame: second day of infusion at 3 g/kg/day

Population: FFAu levels were measured in 2/3 of the samples before the pandemic closed the analytic laboratory, and the other 1/3 were assessed post-pandemic 1.5 years later. The FFAu data are invalid due to an issue associated with the delay, that is, there was severe sample degradation of the FFAu samples that were measured post-pandemic due to prolonged freezing and refreezing-rethawing.

ArmMeasureValue (MEAN)Dispersion
IntralipidUnbound Free Fatty Acid (FFAu) Serum Level0.105 ratio value (R)Standard Deviation 0.008
SMOF LipidUnbound Free Fatty Acid (FFAu) Serum Level0.105 ratio value (R)Standard Deviation 0.008
Secondary

Unbound Free Fatty Acid (FFAu) Serum Level

To measure unbound free fatty acid level, a fluorescent probe called Acrylodan-Labeled Intestinal Fatty Acid Binding Protein 2 (ADIFAB2) was used. The ADIFAB2 fluorescent probe is a fatty acid binding protein complexed with a fluorescent group. Once mixed with a sample, the ADIFAB2 fluorescent probe binds all unbound free fatty acid in the sample; therefore, measurement of fluorescence indicates the amount of unbound free fatty acid in the sample. After binding of the ADIFAB2 fluorescent probe to the sample, fluorescence intensities are measured at two wavelengths (550 nanometers and 457 nanometers), and for this outcome measure the R value is reported. The R value is the ratio of the fluorescence intensity at 550 nanometers to the fluorescence intensity at 457 nanometers.

Time frame: first day of infusion at 3 g/kg/day

Population: FFAu levels were measured in 2/3 of the samples before the pandemic closed the analytic laboratory, and the other 1/3 were assessed post-pandemic 1.5 years later. The FFAu data are invalid due to an issue associated with the delay, that is, there was severe sample degradation of the FFAu samples that were measured post-pandemic due to prolonged freezing and refreezing-rethawing.

ArmMeasureValue (MEAN)Dispersion
IntralipidUnbound Free Fatty Acid (FFAu) Serum Level0.112 ratio value (R)Standard Deviation 0.034
SMOF LipidUnbound Free Fatty Acid (FFAu) Serum Level0.106 ratio value (R)Standard Deviation 0.008

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026