Targeting human milk fortification to improve very preterm infant growth and brain development: study protocol for Nourish, a single-center randomized, controlled clinical trial.
Targeting human milk fortification to improve very preterm infant growth and brain development: study protocol for Nourish, a single-center randomized, controlled clinical trial.
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DOI：
10.1186/s12887-021-02635-x
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发表时间：
2021-04-09
期刊：
影响因子：
2.4
通讯作者：
Inder TE
中科院分区：
文献类型：
--
作者：
Belfort MB;Woodward LJ;Cherkerzian S;Pepin H;Ellard D;Steele T;Fusch C;Grant PE;Inder TE
建议将母乳用于极早产儿，但其常量营养素含量的变化可能会导致发育关键期的营养不良。我们假设，个别针对性的母乳强化在满足大量营养素要求方面比目前的护理标准更有效。我们设计了一项单中心随机对照试验，招募了130名出生在 的31周妊娠的婴儿。参与者将获得强化的产妇和/或巴氏杀菌的捐赠者母乳，但没有配方奶。对于干预组的参与者，除了标准强化外，还将通过蛋白质和脂肪模块单独强化牛奶，以达到基于中红外光谱每日护理点牛奶分析的目标水平。研究饮食将持续到36 周的绝经后年龄(PMA)。临床工作人员和家长将被蒙面到研究组。主要结果包括：1)胎龄36 周时的体长和瘦体质量；2)基于磁共振成像的定量脑部大小和显微结构的测量；以及3)校正年龄2 时的贝利-IV评分。我们期望这项试验将提供有关新生儿重症监护病房(NICU)中个别针对性母乳强化的有效性的重要数据。NCT03977259,2019年6月6日注册。
Human milk is recommended for very preterm infants, but its variable macronutrient content may contribute to undernutrition during a critical period in development. We hypothesize that individually targeted human milk fortification is more effective in meeting macronutrient requirements than the current standard of care. We designed a single-center randomized, controlled trial enrolling 130 infants born < 31 completed weeks’ gestation. Participants will receive fortified maternal and/or pasteurized donor milk but no formula. For participants in the intervention group, milk will be individually fortified with protein and fat modulars to achieve target levels based on daily point-of-care milk analysis with mid-infrared spectroscopy, in addition to standard fortification. The study diet will continue through 36 weeks’ postmenstrual age (PMA). Clinical staff and parents will be masked to study group. Primary outcomes include: 1) body length and lean body mass by air displacement plethysmography at 36 weeks’ PMA; 2) quantitative magnetic resonance imaging-based measures of brain size and microstructure at term equivalent age; and 3) Bayley-IV scales at 2 years’ corrected age. We expect this trial to provide important data regarding the effectiveness of individually targeted human milk fortification in the neonatal intensive care unit (NICU). NCT03977259, registered 6 June, 2019.
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DOI：
10.1073/pnas.1121246109
发表时间：
2012-10-16
影响因子：
11.1
作者：
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