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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months pma

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months pma

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months pma

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months pma for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Average unbound bilirubin (UB) concentration

Number of patients with a prolonged brain stem auditory-evoked response (BAER) V latency

Number of patients with unbound bilirubin (UB) concentration greater than 40 nM/L

Secondary outcome measures

Amount of carbohydrates given to participant in grams per kilograms per day

Amount of fats given to participant in grams per kilograms per day

Amount of protein given to participant in grams per kilograms per day

+14 more

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

904 Previous Clinical Trials

320,840 Total Patients Enrolled

National Center for Advancing Translational Sciences (NCATS)NIH

322 Previous Clinical Trials

401,643 Total Patients Enrolled

Lindsay N Fleig, MDPrincipal 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for participants in this trial?

"According to the clinicaltrials.gov database, this medical trial is presently recruiting patients; it was first posted on June 1st 2021 and modified most recently in October 17th 2022."

Answered by AI

Is the restricted prescribed intralipid (RL) regimen hazardous to patients' health?

"Despite limited clinical evidence for its efficacy, the restricted prescribed intralipid (RL) regimen has been assigned a safety score of 2 due to preliminary data attesting to its non-threatening properties."

Answered by AI

What is the current participant count for this clinical trial?

"Affirmative. According to data hosted on clinicaltrials.gov, this medical study was first listed on June 1st 2021 and is still actively recruiting participants. Aiming for 120 patients in total, the trial is currently looking at one particular site as a potential location."

Answered by AI

What ailments does the restricted prescribed intralipid (RL) regime typically address?

"Patients with nutritional deficiencies, parenteral nutrition needs, and ascorbic acid depletion can be managed through a tightly-controlled regimen of prescribed intralipids (RL)."

Answered by AI

Could you please provide information on any other research projects using the restricted prescribed intralipid (RL) protocol?

"Currently, 13 clinical trials are being conducted for restricted prescribed intralipid (RL) regimen. Of those studies, 3 have reached phase 3. Most of the research is centered around Boston, Massachusetts but there are 27 other test sites conducting experiments with this medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Bilirubin Neurotoxicity (BN) and Neurodevelopmental Impairment (NDI) in Extremely Preterm (EP) Infants: Avoidable by Reducing the Usual Intravenous Lipid (UL) Administration

Lindsay Fleig Holzapfel, MD 2021. "Bilirubin Neurotoxicity (BN) and Neurodevelopmental Impairment (NDI) in Extremely Preterm (EP) Infants: Avoidable by Reducing the Usual Intravenous Lipid (UL) Administration". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04584983.

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