Health TrialsbyHealthPanel

Lipid Infusions to Optimize Nutrition Trial

ConditionsBronchopulmonary DysplasiaNeurodevelopmental Impairment
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-28
SponsorThe University of Texas Health Science Center, Houston

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

inborn <28 weeks gestational age (GA) or ≤1000g birth weight (BW)

survives until 12 hours after birth.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SOLE

    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

    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

Treatment groups

230 Participants
are divided into 2 treatment groups
Group A: SOLEExperimental treatment 1 intervention
Group B: MOLEActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
36 weeks post menstrual age (PMA)

Secondary outcomes

1

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)
2

Relative mole percentages of Docosahexaenoic acid (DHA) in plasma

Time frame
baseline before LE exposure
3

Relative mole percentages of Docosahexaenoic acid (DHA) in plasma

Time frame
end of the intervention period (28±3 postnatal days)
4

Relative mole percentages of Docosahexaenoic acid (DHA) in plasma

Time frame
36 weeks postmenstrual age (±3 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

Source ClinicalTrials.gov
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