Recruiting
Phase 2

MOLE vs. SOLE

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06915441

Conditions

Bronchopulmonary Dysplasia

Neurodevelopmental Impairment

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

SOLE

MOLE

Study Details

Brief summary:

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

Bronchopulmonary Dysplasia

Neurodevelopmental Impairment

Study ID

NCT06915441

Start date

Apr 29, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Jul 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Enrollment

230 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: SOLE

active comparator: MOLE

Interventions

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

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

Primary outcome measure

  • Number of participants free of BPD (infants breathing in room air) [ Time Frame: 36 weeks post menstrual age (PMA) ]

Central Contacts and Locations

Central contacts

Lindsay F Holzapfel, MD, MS

(713) 500-6422Lindsay.N.Fleig@uth.tmc.edu

Emily Stephens

(713) 500-5734Emily.K.Stephens@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Lindsay Holzapfel, MD, MS

713-500-6422Lindsay.N.Fleig@uth.tmc.edu

Emily Stephens

(713) 500-5734Emily.K.Stephens@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • soybean oil-based lipid emulsion (SOLE)
  • mixed oil lipid emulsion (MOLE)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-08-06.