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

Phase 2

Active, not recruiting

• Conditions: Bilirubin Encephalopathy
• Interventions: Drug: usual prescribed intralipid (UL) regimen; Drug: restricted prescribed intralipid (RL) regimen

• Registration Number: NCT04584983
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-10-06
• Study First Posted: 2020-10-14
• Study Start: 2021-01-06
• Disposition First Posted: 2023-08-07
• Primary Completion: 2024-03-15
• Status Verified: 2024-12
• Disposition First Submitted: 2024-12-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2025-01-03
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 134

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
usual prescribed intralipid (UL) regimen	usual prescribed intralipid (UL) regimen	-
restricted prescribed intralipid (RL) regimen	restricted prescribed intralipid (RL) regimen	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States