The LION Study

LION Study Logo

Infants born extremely preterm face serious risks for lung disease and developmental challenges. One key factor in their care is the type of lipid emulsion (a fat mixture) used in intravenous nutrition. For decades, soybean oil–based lipid emulsions (SOLE) were the standard in the U.S. A newer mixed oil lipid emulsion (MOLE), which includes soybean, olive, medium-chain triglyceride, and fish oils, is now widely used, but its effects on long-term outcomes remain uncertain.

The LION Study (Lipid Infusions to Optimize Nutrition) is a randomized controlled trial comparing SOLE and MOLE in extremely preterm infants. By studying nutrition early in life, we aim to learn which lipid emulsion best supports survival without chronic lung disease (bronchopulmonary dysplasia, BPD) and promotes healthy growth and brain development.

Purpose & Aim

Population of the study: Infants <28 weeks’ gestation or ≤1000 grams birthweight, born at Children’s Memorial Hermann Hospital

Measurements: Blood fatty acid levels, urine oxidative stress markers, and pulmonary function tests using the Non-Invasive Respiratory Oscillometry (NIRO)

Outcomes:

    • Primary: Survival without BPD at 36 weeks postmenstrual age
    • Secondary: Growth, pulmonary outcomes, and Bayley Scales of Infant Development (BSID-IV) scores at 2 years

Trial Information

Target Enrollment: ~230 infants
Funding: Internal
Duration of Study: March 2026– March 2029
Follow-up: Through 2 years corrected age, estimated March 2028- March 2031.

Study Principal Investigator 

Lindsay Holzapfel, MD, MS

 

Lindsay F. Holzapfel, MD, MS 

Assistant Professor, Pediatrics, Division of Neonatology
6431 Fannin, MSB 3.236
Houston, TX 77030
(p) 713-500-6422
[email protected]