CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 134 enrolled
Drug / intervention
usual prescribed intralipid (UL) regimen +1 moredrug
Likely dose
usual prescribed intralipid (UL) regimen 1 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04584983
NCT04584983Phase 2Active
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Bilirubin Neurotoxicity (BN) and Neurodevelopmental Impairment (NDI) in Extremely Preterm (EP) Infants: Avoidable by Reducing the Usual Intravenous Lipid (UL) Administration

The University of Texas Health Science Center, Houston·interventional·Posted Oct 14, 2020·Updated Nov 28, 2025

In Brief

A Phase 2 clinical trial evaluating usual prescribed intralipid (UL) regimen and restricted prescribed intralipid (RL) regimen for Bilirubin Encephalopathy. Active but no longer recruiting, targeting 134 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the effect of usual versus reduced lipid intake on unbound bilirubin levels, brainstem auditory evoked responses, and neurodevelopmental outcome at 2 years in extremely preterm infants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBilirubin Encephalopathy
CountriesUnited States
CollaboratorsNational Center for Advancing Translational Sciences (NCATS)

Timeline

Phase 2ActiveOverdue
202120222023202420252026
First PostedOct 14, 2020
Enrollment StartFeb 11, 2021
Primary CompletionMar 14, 2024
Study CompletionJun 14, 2026
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 5.7 years ago

Interventions

usual prescribed intralipid (UL) regimendrug

Intralipid will be started at 1 g/kg/day and routinely advanced by 1 g/kg/day each day to a max of 3 g/kg/day as per usual clinical practice

restricted prescribed intralipid (RL) regimendrug

Intralipid will be started at 0.5 g/kg/day and routinely advanced by 0.5 g/kg/day each day to a max of 1.5 g/kg/day (half rate of usual clinical practice).