NCT04584983View on ClinicalTrials.gov

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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

134

Participants

Timeline

Start Date

January 6, 2021

Primary Completion Date

March 15, 2024

Study Completion Date

July 1, 2026

Conditions
Bilirubin Encephalopathy
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).

Trial Locations (1)

77030

The University of Texas Health Science Center at Houston, Houston

All Listed Sponsors
collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

lead

The University of Texas Health Science Center, Houston

OTHER