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临床试验/NCT06915441
NCT06915441招募中2 期

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

The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2026年4月29日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
230
试验地点
1
主要终点
Number of participants free of BPD (infants breathing in room air)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Hours 至 28 Weeks（Child）
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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.

研究组 & 干预措施

MOLE

Active Comparator

干预措施: MOLE (Drug)

SOLE

Experimental

干预措施: SOLE (Drug)

结局指标

主要结局

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

时间窗: 36 weeks post menstrual age (PMA)

次要结局

  • 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(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))
  • Relative mole percentages of Eicosapentaenoic acid (EPA) in plasma(36 weeks postmenstrual age (±3 days))
  • Change in relative mole percentages of Arachidonic acid (ARA) 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 Arachidonic acid (ARA) in plasma(36 weeks postmenstrual age (±3 days))
  • Change in relative mole percentages of linoleic acid (LA) in plasma(36 weeks postmenstrual age (±3 days))
  • Relative mole percentages of linoleic acid (LA) in plasma(baseline before LE exposure)
  • Change in Urine oxidative stress marker, superoxide dismutase(baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days))
  • Change in Urine oxidative stress marker, lipid peroxidase(baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days))
  • Change in glutathione ratio(baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days))
  • Amount of superoxide dismutase(36 weeks postmenstrual age (±3 days))
  • Glutathione ratio(36 weeks postmenstrual age (±3 days))
  • Amount of lipid peroxidase(36 weeks postmenstrual age (±3 days))
  • Change in lung reactance as assessed by the Non-Invasive Functional Oscillometry Test (FOT)(before discharge (~ 36 weeks post menstrual age), two years)
  • Change in resistance as assessed by the Non-Invasive Functional Oscillometry Test (FOT)(before discharge (~ 36 weeks post menstrual age), two years)
  • Change in impedance as assessed by the Non-Invasive Functional Oscillometry Test (FOT)(before discharge (~ 36 weeks post menstrual age), two years)
  • Change in resonance frequency as assessed by the Non-Invasive Functional Oscillometry Test (FOT)(before discharge (~ 36 weeks post menstrual age), two years)
  • Change in tidal volume as assessed by the Non-Invasive Functional Oscillometry Test (FOT)(before discharge (~ 36 weeks post menstrual age), two years)
  • Change in respiratory rate as assessed by the Non-Invasive Functional Oscillometry Test (FOT)(before discharge (~ 36 weeks post menstrual age), two years)
  • Change in weight of participant(baseline, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age, at discharge (~ 40 weeks post menstrual age))
  • Change in length of participant(baseline, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age, at discharge (~ 40 weeks post menstrual age))
  • Change in head circumference of participant(baseline, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age, at discharge (~ 40 weeks post menstrual age))
  • Number of participants that develop late onset sepsis(Discharge (about 3 months from birth))
  • Number of participants that develop cholestasis(Discharge (about 3 months from birth))
  • Weight of participant(Discharge (about 3 months from birth))
  • Length of participant(Discharge (about 3 months from birth))
  • Head circumference of participant(Discharge (about 3 months from birth))
  • Number of participants that die(at 2 years)
  • Number of participants that develop Neonatal Morbidity(Discharge (about 3 months from birth))
  • Amount of lipid peroxidase(baseline before LE exposure)
  • Relative mole percentages of Eicosapentaenoic acid (EPA) in plasma(baseline before LE exposure)
  • 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))
  • Glutathione ratio(baseline before LE exposure)
  • Glutathione ratio(end of the intervention period (28±3 postnatal days))
  • Relative mole percentages of Eicosapentaenoic acid (EPA) in plasma(end of the intervention period (28±3 postnatal days))
  • Relative mole percentages of Arachidonic acid (ARA) in plasma(baseline before LE exposure)
  • Relative mole percentages of Arachidonic acid (ARA) in plasma(end of the intervention period (28±3 postnatal days))
  • Change in relative mole percentages of linoleic acid (LA) in plasma(baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days))
  • Change in relative mole percentages of linoleic acid (LA) in plasma(end of the intervention period (28±3 postnatal days))
  • Amount of superoxide dismutase(baseline before LE exposure)
  • Amount of superoxide dismutase(end of the intervention period (28±3 postnatal days))
  • Amount of lipid peroxidase(end of the intervention period (28±3 postnatal days))
  • Number of participants that die(Discharge (about 3 months from birth))
  • Neurodevelopmental development as assessed by the Bayley Scales of Infants Development Version IV (BSID-IV)(2 years corrected age)
  • Mechanical ventilation days(Discharge (about 3 months from birth))
  • Number of days participants are exposed to oxygen(Discharge (about 3 months from birth))
  • Number of chronic lung disease re-hospitalizations(after Neonatal Intensive Care Unit (NICU) discharge till 2 years of age)

研究者

发起方
The University of Texas Health Science Center, Houston
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lindsay Fleig Holzapfel, MD

Assistant Professor

The University of Texas Health Science Center, Houston

研究点 (1)

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