NCT06915441

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for phase_2

Timeline
57mo left

Started May 2026

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2028

Expected
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

March 27, 2025

Last Update Submit

April 29, 2026

Conditions

Bronchopulmonary DysplasiaNeurodevelopmental Impairment

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Number of participants free of BPD (infants breathing in room air)

    36 weeks post menstrual age (PMA)

Secondary Outcomes (49)

  • Change in relative mole percentages of Docosahexaenoic acid (DHA) in plasma

    baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days)

  • Relative mole percentages of Docosahexaenoic acid (DHA) in plasma

    baseline before LE exposure

  • Relative mole percentages of Docosahexaenoic acid (DHA) in plasma

    end of the intervention period (28±3 postnatal days)

  • Relative mole percentages of Docosahexaenoic acid (DHA) in plasma

    36 weeks postmenstrual age (±3 days)

  • Change in relative mole percentages of Eicosapentaenoic acid (EPA) in plasma

    baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days)

  • +44 more secondary outcomes

Study Arms (2)

SOLE

EXPERIMENTAL
Drug: SOLE

MOLE

ACTIVE COMPARATOR
Drug: MOLE

Interventions

SOLEDRUG

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

SOLE
MOLEDRUG

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

Eligibility Criteria

Age12 Hours - 28 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Lindsay Holzapfel, MD, MS

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsay F Holzapfel, MD, MS

CONTACT

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

Emily Stephens

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 27, 2025

First Posted

April 8, 2025

Study Start

May 1, 2026

Primary Completion (Estimated)

July 30, 2028

Study Completion (Estimated)

December 31, 2030

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)