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ACTIVE NOT RECRUITING
NCT04584983
PHASE2

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

Sponsor: The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

Any - 27 Weeks

Study Type

INTERVENTIONAL

Enrollment

134

Start Date

2021-02-11

Completion Date

2026-06-14

Last Updated

2025-11-28

Healthy Volunteers

No

Interventions

DRUG

usual prescribed intralipid (UL) regimen

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

DRUG

restricted prescribed intralipid (RL) regimen

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).

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States