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临床试验/NCT05380401
NCT05380401招募中不适用

Metabolic Mechanisms Induced by Enteral Docosahexaenoic Acid (DHA) and Arachidonic Acid (ARA) Supplementation in Preterm Infants

The University of Texas Health Science Center at San Antonio13 个研究点 分布在 1 个国家目标入组 328 人开始时间: 2023年3月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
328
试验地点
13
主要终点
Fatty acid levels in red blood cell (RBC) membranes

研究概览

简要总结

A comprehensive analysis of the impact of exogenous enteral DHA and ARA supplementation on lipid metabolism including the production of downstream derived mediators and how this impacts important biological pathways such as metabolism, inflammation, and organogenic factors.

详细描述

Infants will be randomized to receive the combined enteral DHA/ARA supplement within the first 48 hours after birth to 36 weeks postmenstrual age. The randomization procedure will follow a stratified permuted block scheme to fulfill two goals: (1) randomize infants into one of four arms and (2) ensure an adequate sample size within each week of gestational age. Preterm infants will be randomized using random permuted blocks within each of the 5 birth gestational age strata. When treatment assignment is open and sample size is not overtly large, a block randomization procedure with randomly chosen block sizes can maintain treatment assignment balance and reduce the potential for selection bias. This approach will also ensure that preterm infants of all eligible gestational ages at birth are approximately equally represented in each of 4 arms of the trial, thus ensuring that important comorbidities and standard of care applicable to infants of different gestational ages at birth are also approximately equally distributed across the study arms. There is no placebo for this study. There is no blinding in this study. Consent will also be obtained from the mother of the infant, as they will be asked to provide milk samples if they're breastfeeding their infant, and maternal medical history and demographical data will be recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
— 至 36 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • born between 25 0/7 and 29 6/7 weeks of gestation
  • less than 48 hours of age at first lipid dose (The cohort is defined by gestational age rather than birth weight to avoid an over-represented sample of growth-restricted infants in birth weight defined cohorts.)

排除标准

  • serious congenital anomalies
  • conditions at birth that will require surgery prior to discharge
  • imminent death such that withdrawal of intensive care support is anticipated within the first 72 hours after birth

研究组 & 干预措施

DHA/ARA initially then no supplement

Other

DHA/ARA supplement from enrollment to 31 6/7 weeks post-menstrual age (PMA) then no supplement from 32 to 36 weeks' PMA, "x- on/off"

干预措施: Enfamil® DHA & ARA Supplement for Special Dietary Use (Dietary Supplement)

DHA/ARA supplement

Other

DHA/ARA supplement throughout the duration of the protocol, "d-on"

干预措施: Enfamil® DHA & ARA Supplement for Special Dietary Use (Dietary Supplement)

No DHA/ARA supplement

No Intervention

no DHA/ARA supplement throughout the duration of the protocol, "d-off"

No supplement initially then DHA/ARA supplement

Other

No DHA/ARA supplement till 31 6/7 weeks' then long-chain polyunsaturated fatty acids (LCPUFA) supplement from 32 to 36 weeks PMA, "x-off/on"

干预措施: Enfamil® DHA & ARA Supplement for Special Dietary Use (Dietary Supplement)

结局指标

主要结局

Fatty acid levels in red blood cell (RBC) membranes

时间窗: Baseline to 36 weeks

Change in fatty acid levels in RBC membranes

Change in biomarker Resolvin E1

时间窗: Baseline to 36 weeks

Biomarker reflective of system development and function will be measured. There are no specific levels since there is no normative data in neonates.

Change in Protectin/Neuroprotectin

时间窗: Baseline to 36 weeks

Levels of protectin/neuroprotectin and fatty acids in the n3 and n6 pathways will be measured.

Change in circulating biomarker Lipoxin A4

时间窗: Baseline to 36 weeks

Biomarker reflective of system development and function will be measured. There are no specific levels since there is no normative data in neonates.

Fatty acid levels in plasma

时间窗: Baseline to 36 weeks

Change in lipid metabolites reflected by levels in plasma

Change in biomarker Resolvin D1

时间窗: Baseline to 36 weeks

Biomarker reflective of system development and function will be measured. There are no specific levels since there is no normative data in neonates.

次要结局

  • Change in infant weigh(Baseline to 36 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (13)

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