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Recruiting NCT06915441

Lipid Infusions to Optimize Nutrition Trial

Phase II Interventional Bronchopulmonary Dysplasia Neurodevelopmental Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SOLE, MOLE.
Who it may be relevant to
Registry conditions: Bronchopulmonary Dysplasia, Neurodevelopmental Impairment. Basic parameters: 12 Hours — 28 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Lipid Infusions to Optimize Nutrition (LION) and Minimize Bronchopulmonary Dysplasia and Neurodevelopmental Impairment in Extremely Preterm Infants: A Randomized Comparative Effectiveness Trial

Overview

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

Interventions

  • 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
  • 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

Primary outcome measures

  • Number of participants free of BPD (infants breathing in room air) [Time frame: 36 weeks post menstrual age (PMA)]
Secondary outcome measures (12)
  • Change in relative mole percentages of Docosahexaenoic acid (DHA) in plasma [Time frame: 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 [Time frame: baseline before LE exposure]
  • Relative mole percentages of Docosahexaenoic acid (DHA) in plasma [Time frame: end of the intervention period (28±3 postnatal days)]
  • Relative mole percentages of Docosahexaenoic acid (DHA) in plasma [Time frame: 36 weeks postmenstrual age (±3 days)]
  • Change in relative mole percentages of Eicosapentaenoic acid (EPA) in plasma [Time frame: baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days)]
  • Relative mole percentages of Eicosapentaenoic acid (EPA) in plasma [Time frame: baseline before LE exposure]
  • Relative mole percentages of Eicosapentaenoic acid (EPA) in plasma [Time frame: end of the intervention period (28±3 postnatal days)]
  • Relative mole percentages of Eicosapentaenoic acid (EPA) in plasma [Time frame: 36 weeks postmenstrual age (±3 days)]
  • Change in relative mole percentages of Arachidonic acid (ARA) in plasma [Time frame: baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days)]
  • Relative mole percentages of Arachidonic acid (ARA) in plasma [Time frame: baseline before LE exposure]
  • Relative mole percentages of Arachidonic acid (ARA) in plasma [Time frame: end of the intervention period (28±3 postnatal days)]
  • Relative mole percentages of Arachidonic acid (ARA) in plasma [Time frame: 36 weeks postmenstrual age (±3 days)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT06915441 · HSC-MS-24-1129

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗