Lipid Infusions to Optimize Nutrition Trial
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-28
SponsorThe University of Texas Health Science Center, Houston
About this trial
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
Eligibility criteria
Qualifiers
inborn <28 weeks gestational age (GA) or ≤1000g birth weight (BW)
survives until 12 hours after birth.
Disqualifiers
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
Treatments tested in this trial
- SOLE
- MOLE
Treatment groups
230 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov