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Not yet recruiting Phase 2 NCT06915441

Lipid Infusions to Optimize Nutrition Trial

Phase 2 – studying effectiveness and dosage
Conditions: Bronchopulmonary Dysplasia Neurodevelopmental Impairment

Sponsor: The University of Texas Health Science Center, Houston

trial.available_in: БГ
Overview
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
Who can participate
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.
Interventions
SOLE
DRUG
MOLE
DRUG
Locations 1
United States (1)
The University of Texas Health Science Center at Houston
Houston , Texas
Technical details
Status
Not yet recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
12 Hours
Maximum age
28 Weeks
Healthy volunteers
No
Start date
01.05.2026
Completion date
31.12.2030
Registry ID
NCT06915441
Source
clinicaltrials.gov
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