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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
Sponsor: The University of Texas Health Science Center, Houston
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
Conditions
Interventions
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
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