NCT04584983

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 27 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Bilirubin Encephalopathy

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2021-02-11
• Primary completion: 2024-03-14
• Completion: 2026-06-14
• First posted: 2020-10-14
• Last updated: 2025-11-28
• Results posted: 2025-11-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study