PrematurityPhase 4NCT03857646

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

A Phase 4 study testing Intralipid, 20% Intravenous Emulsion and Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipid in people with Prematurity, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 0 to 8 days
Conditions the study is for: Prematurity
What is being tested?: Intralipid, 20% Intravenous Emulsion and Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipid
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteUnited States
Study dates: 2 Mar 2019to 11 Jun 2020
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 0 to 8 days
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University Texas Houston HSC
Houston, Texas, 77030

Other trials in United States

About this study

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.

Conditions: Prematurity
Being tested: Intralipid, 20% Intravenous Emulsion, Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipid
Keywords: parenteral nutrition, lipid emulsion, free bilirubin, free fatty acids
Medical subject headings: Premature Birth, Hyperphagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intralipid, 20% Intravenous EmulsionDrug
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.
Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipidDrug
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.

Study groups in NCT03857646
Study group	Role	What they receive
Intralipid	Other	Not described Receives: Drug: Intralipid, 20% Intravenous Emulsion
Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipid	Other	Not described Receives: Drug: Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipid

What is being measured

The primary outcome is the main question the study is designed to answer.

Free Bilirubin (UB) Serum Levels
Measured: first day of infusion at 3 g/kg/day
Free Bilirubin (UB) Serum Levels
Measured: second day of infusion at 3 g/kg/day

Secondary outcomes (7)

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.
Measured: first day of infusion at 3 g/kg/day
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.
Measured: second day of infusion at 3 g/kg/day
Free Fatty Acid (Total) Serum Level
Measured: second day of infusion at 3 g/kg/day
Number of Participants With Direct Bilirubin >1.8 Milligrams Per Deciliter (mg/dL)
Measured: first and/or second days of infusion at 3 g/kg/day
Number of Participants With Peak Serum Triglyceride Level >350 mg/dl
Measured: first or second days of infusion at 3 g/kg/day
Mean Serum Triglyceride Level
Measured: first day of infusion at 3 g/kg/day
Mean Serum Triglyceride Level
Measured: second day of infusion at 3 g/kg/day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 201911 Jun 2020

First posted28 Feb 2019
Study start2 Mar 2019
Primary completion11 Jun 2020
Study completion11 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PrematurityStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03857646
Sponsor's protocol ID: HSC-MS-18-1000
Status last verified: Feb 2025
First submitted: 26 Feb 2019
Last updated: 3 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
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Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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All Prematurity trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Lipid Emulsions on Free Fatty Acids and Free Bilirubin in Premature Newborns
ClinicalTrials.gov ID: NCT03857646
Acronym / sponsor ID: HSC-MS-18-1000
Conditions: Prematurity
Keywords: parenteral nutrition, lipid emulsion, free bilirubin, free fatty acids
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Study start: 2 Mar 2019 (actual)
Primary completion: 11 Jun 2020 (actual)
Study completion: 11 Jun 2020 (actual)
First posted: 28 Feb 2019 (actual)
Results: Posted 3 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intralipid	Other	Drug: Intralipid, 20% Intravenous Emulsion
Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipid	Other	Drug: Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipid

Who may qualify

Ages: 0 to 8 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intralipid, 20% Intravenous EmulsionLipids 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.	Drug	Intralipid
Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipidLipids 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.	Drug	Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipid

Primary outcome

Free Bilirubin (UB) Serum Levels
Time frame: first day of infusion at 3 g/kg/day
Free Bilirubin (UB) Serum Levels
Time frame: second day of infusion at 3 g/kg/day

7 secondary outcomes

Unbound Free Fatty Acid (FFAu) Serum Level
Time frame: first day of infusion at 3 g/kg/day
Unbound Free Fatty Acid (FFAu) Serum Level
Time frame: second day of infusion at 3 g/kg/day
Free Fatty Acid (Total) Serum Level
Time frame: second day of infusion at 3 g/kg/day
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
Number of Participants With Peak Serum Triglyceride Level >350 mg/dl
Time frame: first or second days of infusion at 3 g/kg/day
Mean Serum Triglyceride Level
Time frame: first day of infusion at 3 g/kg/day
Mean Serum Triglyceride Level
Time frame: second day of infusion at 3 g/kg/day

Results and safety

Results posted to the registry on 3 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intralipid	33	29
Soybean Oil Medium-chain Triglycerides Olive Oil Fish Oil (SMOF) Lipid	33	25

Primary outcome: Free Bilirubin (UB) Serum Levels

Time frame: first day of infusion at 3 g/kg/day. Mean (Standard Deviation). Unit: Nanomoles/Liter (nM)

Measure	Intralipid n = 30	SMOF Lipid n = 29
Value	10.5 (7.5)	9.4 (7.0)

Population analysed: 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.

Primary outcome: Free Bilirubin (UB) Serum Levels

Time frame: second day of infusion at 3 g/kg/day. Mean (Standard Deviation). Unit: Nanomoles/Liter (nM)

Measure	Intralipid n = 29	SMOF Lipid n = 25
Value	10.2 (7.8)	7.4 (2.2)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: about 5 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intralipid	2 of 33 (6.1%)	0 of 33 (0%)	2 of 33
SMOF Lipid	1 of 33 (3%)	1 of 33 (3%)	1 of 33

Limitations and caveats (from the sponsor): UB and FFAu levels were measured in 2/3 of the samples before the pandemic, and the other 1/3 were assessed post-pandemic 1.5 years later. The UB and FFAu data are invalid due to 2 issues associated with the delay: (1) the UB measurement device was recalibrated in the interim such that the UB results pre vs post recalibration are incomparable and (2) for FFAu, there was severe sample degradation of the samples measured post-pandemic due to prolonged freezing and refreezing-rethawing.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Prematurity

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nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
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Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cody Arnold, MD study director

UT Houston HSC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Free Bilirubin (UB) Serum Levels (time frame: first day of infusion at 3 g/kg/day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03857646.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.