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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 6, 2024

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).

Arms, Groups and Cohorts

  • Active Comparator: usual prescribed intralipid (UL) regimen
  • Experimental: restricted prescribed intralipid (RL) regimen

Clinical Trial Outcome Measures

Primary Measures

  • Number of patients with unbound bilirubin (UB) concentration greater than 40 nM/L
    • Time Frame: within first 14 days of life
  • Average unbound bilirubin (UB) concentration
    • Time Frame: within first 14 days of life
    • 6 UB measurements will be taken per participant .Average of the 6 readings will be reported
  • Number of patients with a prolonged brain stem auditory-evoked response (BAER) V latency
    • Time Frame: 34-36 weeks post menstrual age(PMA)

Secondary Measures

  • Mean UB concentration
    • Time Frame: within first 14 days of life
  • Number of patients with UB measurements greater than 40 nM/L
    • Time Frame: within first 14 days of life
  • Peak UB concentration
    • Time Frame: within first 14 days of life
  • Total unbound free fatty acids (FFA)
    • Time Frame: within first 14 days of life
    • 6 FFA measurements will be taken for each participant.Average of the 6 readings will be reported
  • Peak total unbound free fatty acids (FFA)
    • Time Frame: within first 14 days of life
  • Peak total serum bilirubin
    • Time Frame: within first 14 days of life
  • Number of patients with Direct bilirubin greater than 1.5 mg/dL
    • Time Frame: Before discharge (discharge is on average 3 months after birth)
  • Amount of protein given to participant in grams per kilograms per day
    • Time Frame: within first 14 days of life
  • Amount of carbohydrates given to participant in grams per kilograms per day
    • Time Frame: within first 14 days of life
  • Amount of fats given to participant in grams per kilograms per day
    • Time Frame: within first 14 days of life
  • Change in weight(grams/kilogram/day)
    • Time Frame: birth,day 28
  • Change in weight(grams/kilogram/day)
    • Time Frame: birth,post menstrual age 36 weeks
  • Number of patients with Bronchopulmonary dysplasia
    • Time Frame: 36 weeks post menstrual age
  • number of patients with Perinatal and hospital acquired sepsis episodes
    • Time Frame: birth until discharge ( discharge will be about 3 months post birth)
  • Number of patients who died
    • Time Frame: 24 months PMA
  • Number of patients with neurodevelopmental impairment
    • Time Frame: 24 months PMA
  • Number of patients with hearing loss
    • Time Frame: 24 months PMA
  • Number of patients with cerebral palsy
    • Time Frame: 24 months PMA

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 27 Weeks

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Texas Health Science Center, Houston
  • Provider of Information About this Clinical Study
    • Principal Investigator: Lindsay Fleig Holzapfel, MD, Assistant Professor – The University of Texas Health Science Center, Houston
  • Overall Official(s)
    • Lindsay N Fleig, MD, Principal Investigator, The University of Texas Health Science Center, Houston
  • Overall Contact(s)
    • Lindsay N Fleig, MD, (713) 500-6422, Lindsay.N.Fleig@uth.tmc.edu

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