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Purpose

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

Conditions

Eligibility

Eligible Ages
Between 12 Hours and 28 Weeks
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
SOLE
  • Drug: SOLE
    Participants will first receive LE at 1 g/kg/day, then will advance to 2 g/kg/day and lastly to 3 g/kg/day as tolerated to titrate based on triglyceride level <250 mg/dL, per clinical team
Active Comparator
MOLE
  • Drug: MOLE
    Participants will first receive LE at 1 g/kg/day, then will advance to 2 g/kg/day and lastly to 3 g/kg/day as tolerated to titrate based on triglyceride level <250 mg/dL, per clinical team

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Lindsay Holzapfel, MD, MS
713-500-6422
Lindsay.N.Fleig@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Lindsay F Holzapfel, MD, MS
(713) 500-6422
Lindsay.N.Fleig@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.