Lipid Study
The Lipid Study is a comparison of usual and reduced dosing of a necessary intravenous fat (lipid emulsion) in extremely preterm infants. Since the invention of lipid emulsions for use in adult patients in the 1970s, no clinical trials have investigated into the safety for babies born extremely premature. There is potential that usual lipid emulsion doses (2-3 g/kg/day) can cause displacement of bilirubin from albumin and allowing for bilirubin to cross the blood brain barrier more easily. Bilirubin is an orange-yellow pigment that is that breakdown product of the heme protein in red blood cells and is excreted in urine and stool. When excess bilirubin crosses into the brain, it deposits in the brainstem area responsible for hearing and motor functioning, and can cause irreversible brain damage, or kernicterus. On the other hand, lower doses of lipid emulsion provide fewer nutrients to premature babies, which are important for growth.
In this study, we compare two different doses of fat emulsion in babies with birthweight <750g. The primary outcome compared is a marker of bilirubin-related injury (the brain waves responsible for hearing called wave V latency on Brainstem Auditory Evoked Responses (BAERs)). One group will receive the usual dose (max 3 g/kg/day) and the other group a reduced dose (max 1.5 g/kg/day) during the first 14 days. Infants enrolled in the study are also enrolled in the NICHD Neonatal Research Network (NRN) Trial of Cycled Phototherapy (NCT 03927833), which compares 2 different doses of phototherapy. This will allow us to determine whether there is a relationship between fat emulsion dose and phototherapy dose.
Purpose & Aim
Population of the study: Extremely preterm infants <27 weeks’ gestation; or ≤750 grams birthweight
Intervention: Reduced Lipid dosing (half usual care dose)
Control (Usual care in our hospital): Usual Lipid dosing
Outcome: unbound bilirubin levels, wave V latency on BAER
Trial Information
Target Recruitment: 120
Sponsor: NIH Center for Clinical and Translational Sciences (NCATS)
Funder: NIH NCATS KL2 Career Development Award (5KL2TR003168), July 2021 – July 2024
Duration of Study: January 2021 – January 2024
Study Principal Investigator
Assistant Professor
Department of Pediatrics, Division of Neonatology
Institute for Clinical Research and Learning Healthcare
6431 Fannin, MSB 3.236
Houston, TX 77030
(p): 713-500-6422
Lindsay.N.Fleig@uth.tmc.edu
Links
Protocol
ClinicalTrials.gov
Provider Handout Sheet
Parent Information Sheet: English | Spanish