Lipid Infusions to Optimize Nutrition Trial (LION)

The University of Texas System (UT)

Status and phase: Begins enrollment this month; Phase 2

Conditions: Neurodevelopmental Impairment; Bronchopulmonary Dysplasia

Treatments: Drug: MOLE; Drug: SOLE

Study type: Interventional

Funder types: Other

Identifiers

NCT06915441

HSC-MS-24-1129

Details and patient eligibility

About

The purpose of this study is to identify survival free of bronchopulmonary dysplasia (BPD), fatty acid profiles, and early biochemical measures for oxidative stress comparing mixed oil lipid emulsion (MOLE) vs soybean oil-based lipid emulsion (SOLE) and to establish whether MOLE or SOLE is more effective in minimizing pulmonary outcomes, neonatal morbidities, long-term morbidity and mortality, and improving discharge growth and Bayley Scales of Infant Development Fourth Edition (BSID-IV) neurodevelopmental assessment at two years

Enrollment: 230 estimated patients

Sex: All

Ages: 12 hours to 28 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• inborn <28 weeks gestational age (GA) or ≤1000g birth weight (BW)
• survives until 12 hours after birth.

Exclusion criteria

• Infants who are unable to be enrolled by 96 hours postnatal age
• Major anomaly
• Overt non-bacterial infection
• Infants likely to expire soon defined as limiting or withdrawal of intensive care recommended or requested by the parents.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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230 participants in 2 patient groups

SOLE

Experimental group

Treatment:

Drug: SOLE

MOLE

Active Comparator group

Treatment:

Drug: MOLE