NCT03857646

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 28, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

March 2, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2020

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

March 3, 2025

Completed
Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

1.3 years

First QC Date

February 26, 2019

Results QC Date

June 30, 2022

Last Update Submit

February 12, 2025

Conditions

Prematurity

Keywords

parenteral nutritionlipid emulsionfree bilirubinfree fatty acids

Outcome Measures

Primary Outcomes (2)

  • Free Bilirubin (UB) Serum Levels

    first day of infusion at 3 g/kg/day

  • Free Bilirubin (UB) Serum Levels

    second day of infusion at 3 g/kg/day

Secondary Outcomes (7)

  • Unbound Free Fatty Acid (FFAu) Serum Level

    first day of infusion at 3 g/kg/day

  • Unbound Free Fatty Acid (FFAu) Serum Level

    second day of infusion at 3 g/kg/day

  • 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

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

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

  • +2 more secondary outcomes

Study Arms (2)

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

Interventions

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.

Intralipid
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.

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

Eligibility Criteria

Age0 Days - 8 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Texas Houston HSC

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Premature BirthHyperphagia

Interventions

soybean oil, phospholipid emulsionLipids

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

Title
Cody Arnold
Organization
Stanford University
codya@stanford.edu
(650) 723-8772

Study Officials

  • Cody Arnold, MD

    UT Houston HSC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

February 26, 2019

First Posted

February 28, 2019

Study Start

March 2, 2019

Primary Completion

June 11, 2020

Study Completion

June 11, 2020

Last Updated

March 3, 2025

Results First Posted

March 3, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)