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Lipid Emulsion

Intralipid Regimens for Neurodevelopment in Preterm Infants

Phase 2
Recruiting
Led By Lindsay N Fleig, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No major congenital anomaly or overt nonbacterial infection
Be younger than 18 years old
Must not have
Has received Intralipid
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within first 14 days of life
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial will compare two different diets for extremely premature infants to see which leads to better neurodevelopmental outcomes.

Who is the study for?
This trial is for extremely preterm infants without major birth defects or infections, whose mothers consented to the Neonatal Research Network Cycled Phototherapy Trial. Infants who have already received intralipid treatments are not eligible.
What is being tested?
The study compares two lipid intake regimens in premature babies: a restricted and a usual prescribed intralipid regimen. It aims to see how these affect bilirubin levels, auditory brain responses, and neurodevelopment by age 2.
What are the potential side effects?
While specific side effects are not listed, changes in lipid administration could potentially impact growth, nutrition balance, and liver function. Close monitoring will likely assess any adverse effects on infant development.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I do not have any major birth defects or active infections.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have received Intralipid treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within first 14 days of life
This trial's timeline: 3 weeks for screening, Varies for treatment, and within first 14 days of life for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Average unbound bilirubin (UB) concentration
Secondary study objectives
Total unbound free fatty acids (FFA)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: restricted prescribed intralipid (RL) regimenExperimental Treatment1 Intervention
Group II: usual prescribed intralipid (UL) regimenActive Control1 Intervention

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
347,740 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
377 Previous Clinical Trials
412,907 Total Patients Enrolled
Lindsay N Fleig, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
Lindsay F Holzapfel, MD, MSPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Media Library

restricted prescribed intralipid (RL) regimen (Lipid Emulsion) Clinical Trial Eligibility Overview. Trial Name: NCT04584983 — Phase 2
Kernicterus Research Study Groups: restricted prescribed intralipid (RL) regimen, usual prescribed intralipid (UL) regimen
Kernicterus Clinical Trial 2023: restricted prescribed intralipid (RL) regimen Highlights & Side Effects. Trial Name: NCT04584983 — Phase 2
restricted prescribed intralipid (RL) regimen (Lipid Emulsion) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04584983 — Phase 2
~24 spots leftby Dec 2025
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