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

The University of Texas System (UT)

Status and phase: Active, not recruiting; Phase 2

Conditions: Bilirubin Encephalopathy

Treatments: Drug: restricted prescribed intralipid (RL) regimen; Drug: usual prescribed intralipid (UL) regimen

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04584983

KL2TR003168 (U.S. NIH Grant/Contract)

HSC-MS-20-0916

Details and patient eligibility

About

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.

Enrollment: 134 patients

Sex: All

Ages: Under 27 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

usual prescribed intralipid (UL) regimen

Active Comparator group

Treatment:

Drug: usual prescribed intralipid (UL) regimen

restricted prescribed intralipid (RL) regimen

Experimental group

Treatment:

Drug: restricted prescribed intralipid (RL) regimen