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

Purpose

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.

Condition

  • Bilirubin Encephalopathy

Eligibility

Eligible Ages
Under 27 Weeks
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • no major congenital anomaly or overt nonbacterial infection - mother has consented to inclusion of the infant for the Neonatal Research Network (NRN) Cycled Phototherapy Trial

Exclusion Criteria

  • has received Intralipid

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
usual prescribed intralipid (UL) regimen
  • 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
Experimental
restricted prescribed intralipid (RL) regimen
  • 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).

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Lindsay F Holzapfel, MD, MS
713-500-6422
Lindsay.N.Fleig@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Lindsay F Holzapfel, MD, MS
(713) 500-6422
Lindsay.N.Fleig@uth.tmc.edu