Lipid Infusions to Optimize Nutrition Trial

NCT ID: NCT06915441

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-01

Study Completion Date

2030-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Bronchopulmonary Dysplasia Neurodevelopmental Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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SOLE

Group Type EXPERIMENTAL

SOLE

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

MOLE

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Hours

Maximum Eligible Age

28 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Lindsay Fleig Holzapfel, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lindsay Holzapfel, MD, MS

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Lindsay F Holzapfel, MD, MS

Role: CONTACT

(713) 500-6422

Emily Stephens

Role: CONTACT

(713) 500-5734

Facility Contacts

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Lindsay Holzapfel, MD, MS

Role: primary

713-500-6422

Emily Stephens

Role: backup

(713) 500-5734

Other Identifiers

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HSC-MS-24-1129

Identifier Type: -

Identifier Source: org_study_id

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