Pickler Rita H, Wetzel Paul A, Meinzen-Derr Jareen, Tubbs-Cooley Heather L, Moore Margo
Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH, 45229, USA.
Virginia Commonwealth University, 401 West Main Street, PO Box 843067, Richmond, VA, USA.
Trials. 2015 Jun 4;16:255. doi: 10.1186/s13063-015-0781-3.
Neurobehavioral disabilities occur in 5-15% of preterm infants with an estimated 50-70% of very low birth weight preterm infants experiencing later dysfunction, including cognitive, behavioral, and social delays that often persist into adulthood. Factors implicated in poor neurobehavioral and developmental outcomes are hospitalization in the neonatal intensive care unit (NICU) and inconsistent caregiving patterns. Although much underlying brain damage occurs in utero or shortly after birth, neuroprotective strategies can stop lesions from progressing, particularly when these strategies are used during the most sensitive periods of neural plasticity occurring months before term age. The purpose of this randomized trial is to test the effect of a patterned feeding experience on preterm infants' neurobehavioral organization and development, cognitive function, and clinical outcomes.
This trial uses an experimental, longitudinal, 2-group design with 120 preterm infants. Infants are enrolled within the first week of life and randomized to an experimental group receiving a patterned feeding experience from the first gavage feeding through discharge or to a control group receiving usual feeding care experience. The intervention involves a continuity of tactile experiences associated with feeding to train and build neuronal networks supportive of normal infant feeding experience. Primary outcomes are neurobehavioral organization as measured by Neurobehavioral Assessment of the Preterm Infant at 3 time points: the transition to oral feedings, NICU discharge, and 2 months corrected age. Secondary aims are cognitive function measured using the Bayley Scales of Infant and Toddler Development, Third Edition at 6 months corrected age, neurobehavioral development (sucking organization, feeding performance, and heart rate variability), and clinical outcomes (length of NICU stay and time to full oral feeding). The potential effects of demographic and biobehavioral factors (perinatal events and conditions of maternal or fetal/newborn origin and immunologic and genetic biomarkers) on the outcome variables will also be considered.
Theoretically, the intervention provided at a critical time in neurologic system development and associated with a recurring event (feeding) should enhance neural connections that may be important for later development, particularly language and other cognitive and neurobehavioral organization skills.
NCT01577615 11 April 2012.
神经行为障碍发生在5% - 15%的早产儿中，据估计，出生体重极低的早产儿中有50% - 70%日后会出现功能障碍，包括认知、行为和社交方面的延迟，且这些延迟往往会持续到成年。与不良神经行为和发育结局相关的因素包括新生儿重症监护病房（NICU）住院治疗以及不一致的护理模式。尽管许多潜在的脑损伤发生在子宫内或出生后不久，但神经保护策略可以阻止损伤进展，特别是当这些策略在足月前几个月神经可塑性最敏感的时期使用时。这项随机试验的目的是测试一种模式化喂养体验对早产儿神经行为组织与发育、认知功能和临床结局的影响。
本试验采用实验性、纵向、两组设计，纳入120名早产儿。婴儿在出生后第一周内入组，并随机分为实验组和对照组，实验组从首次鼻饲喂养至出院接受模式化喂养体验，对照组接受常规喂养护理体验。干预措施包括与喂养相关的一系列触觉体验，以训练和构建支持正常婴儿喂养体验的神经网络。主要结局是通过在3个时间点对早产儿进行神经行为评估来衡量神经行为组织，这3个时间点分别为：过渡到经口喂养、NICU出院时以及矫正年龄2个月时。次要目标是在矫正年龄6个月时使用贝利婴幼儿发展量表第三版测量认知功能、神经行为发育（吸吮组织、喂养表现和心率变异性）以及临床结局（NICU住院时长和完全经口喂养所需时间）。还将考虑人口统计学和生物行为因素（围产期事件以及母亲或胎儿/新生儿来源的状况和免疫及遗传生物标志物）对结局变量的潜在影响。
从理论上讲，在神经系统发育的关键时期提供的干预措施，且与反复出现的事件（喂养）相关，应该会增强对后期发育可能很重要的神经连接，特别是语言以及其他认知和神经行为组织技能。
NCT01577615 2012年4月11日。
