Prematurity
Conditions
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.
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
Study design
Eligibility
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
| Measure | Time frame |
|---|---|
| Free Bilirubin (UB) Serum Levels | first day of infusion at 3 g/kg/day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Serum Triglyceride Level | first day of infusion at 3 g/kg/day | — |
| Number of Participants With Peak Serum Triglyceride Level >350 mg/dl | first or second days of infusion at 3 g/kg/day | — |
| Unbound Free Fatty Acid (FFAu) Serum Level | first day of infusion at 3 g/kg/day | 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. |
| Free Fatty Acid (Total) Serum Level | second 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
| Arm | Count |
|---|---|
| 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 |
| Total | 66 |
Baseline characteristics
| Characteristic | Intralipid | SMOF Lipid | Total |
|---|---|---|---|
| Age, Continuous | 1.81 days STANDARD_DEVIATION 0.53 | 1.83 days STANDARD_DEVIATION 0.37 | 1.82 days STANDARD_DEVIATION 0.45 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 18 Participants | 18 Participants | 36 Participants |
| Sex: Female, Male Male | 15 Participants | 15 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 33 | 1 / 33 |
| other Total, other adverse events | 0 / 33 | 1 / 33 |
| serious Total, serious adverse events | 2 / 33 | 1 / 33 |
Outcome results
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intralipid | Free Bilirubin (UB) Serum Levels | 10.5 Nanomoles/Liter (nM) | Standard Deviation 7.5 |
| SMOF Lipid | Free Bilirubin (UB) Serum Levels | 9.4 Nanomoles/Liter (nM) | Standard Deviation 7 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intralipid | Free Bilirubin (UB) Serum Levels | 10.2 Nanomoles/Liter (nM) | Standard Deviation 7.8 |
| SMOF Lipid | Free Bilirubin (UB) Serum Levels | 7.4 Nanomoles/Liter (nM) | Standard Deviation 2.2 |
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.
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intralipid | Mean Serum Triglyceride Level | 177.23 milligrams per deciliter (mg/dL) | Standard Deviation 91.73 |
| SMOF Lipid | Mean Serum Triglyceride Level | 139.37 milligrams per deciliter (mg/dL) | Standard Deviation 74.63 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intralipid | Mean Serum Triglyceride Level | 153.53 milligrams per deciliter (mg/dL) | Standard Deviation 63.84 |
| SMOF Lipid | Mean Serum Triglyceride Level | 159.5 milligrams per deciliter (mg/dL) | Standard Deviation 120.23 |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intralipid | Number of Participants With Direct Bilirubin >1.8 Milligrams Per Deciliter (mg/dL) | 1 Participants |
| SMOF Lipid | Number of Participants With Direct Bilirubin >1.8 Milligrams Per Deciliter (mg/dL) | 0 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intralipid | Number of Participants With Peak Serum Triglyceride Level >350 mg/dl | 1 Participants |
| SMOF Lipid | Number of Participants With Peak Serum Triglyceride Level >350 mg/dl | 2 Participants |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intralipid | Unbound Free Fatty Acid (FFAu) Serum Level | 0.105 ratio value (R) | Standard Deviation 0.008 |
| SMOF Lipid | Unbound Free Fatty Acid (FFAu) Serum Level | 0.105 ratio value (R) | Standard Deviation 0.008 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intralipid | Unbound Free Fatty Acid (FFAu) Serum Level | 0.112 ratio value (R) | Standard Deviation 0.034 |
| SMOF Lipid | Unbound Free Fatty Acid (FFAu) Serum Level | 0.106 ratio value (R) | Standard Deviation 0.008 |