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临床试验/NCT01628510
NCT01628510已完成不适用

Randomized Clinical Trial Investigating the Developmental Effects of Two Different Methods of Neonatal Positioning in the NICU

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
NICU Network Neurobehavioral Scale (NNNS)

研究概览

简要总结

The purpose of this study is to investigate the developmental effects of two different types of positioning used with premature infants in the neonatal intensive care unit.

详细描述

Infants born prematurely have a high risk of developmental impairment. Subsequently, preterm infants are often seen by therapy services in the neonatal intensive care unit and are often recommended for early intervention services at discharge. One of the earliest interventions for preterm infants in the Neonatal Intensive Care Unit (NICU) is positioning, as altered positioning can have a significant impact on later function.

Preterm infants have a positioning disadvantage from early on in their development. The final trimester of pregnancy promotes the flexed position, when the infant is crowded by the uterine environment and experiences rapid brain growth, mediating flexion and midline orientation. When infants are born too soon, they miss the in utero flexion positioning. They lack the central nervous system maturity to enable flexion and do not have the tone and strength for movement against gravity. In addition, preterm infants are confronted with altered sensory experiences, resulting from static, extended positioning and environmental factors associated with life and medical interventions outside the womb. Therefore, early transition to the extrauterine environment is a challenge for premature infants, as they face overwhelming sensory stimuli that their bodies are not yet prepared to process.

It has been demonstrated that the positioning of the preterm infant differs from that of a full term infant. The tightly flexed positioning of a full term newborn is called physiological flexion. It involves symmetrical flexion of the extremities, shoulder protraction, and posterior pelvic tilt.

Physiological flexion has developmental importance. This positioning enables infants to remain motorically and physiologically organized and facilitates self-soothing and self-regulation behaviors, such as sucking and hand to mouth contact. The flexed position provides the infant with a sense of containment and security, which mimics the intrauterine environment. In addition, physiological flexion is associated with greater extremity contact with the trunk, which imitates the womb and gives infants sensory feedback.

The benefits of early physiological flexion can have long term benefits on development. Many neonatal reflexes, such as upper and lower extremity recoil, palmar and plantar grasp, and pull to sit are mediated by flexion response. These early flexion responses form the foundation for later movement acquisition. Physiological flexion also promotes later development of normal balance and posture. Ideal posture supports the development of head control, sitting, crawling, walking, transferring from one position to another, and manipulating objects. Due to missing the third trimester, preterm infants are at risk for assuming suboptimal positions, thus missing the early benefits of physiological flexion.

研究设计

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

入排标准

年龄范围
1 Hour 至 7 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Premature infants born at or before 32 weeks gestation

排除标准

  • Congenital Anomaly

研究组 & 干预措施

Traditional NICU Positioning

Active Comparator

Methods of positioning in the NICU have been used for several decades. These methods aim at providing containment and flexion and may consist of interventions such as swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper® The continued use of these methods of positioning is the control group in the current study.

干预措施: Traditional NICU Positioning (Other)

Dandle Roo/Dandle Wrap

Experimental

The new Dandle Roo and Dandle Wrap were developed by NICU professionals to support the neurodevelopment of the preterm infant, and this device is produced by Dandle Lion Medical. The Dandle Roo/Wrap provides all around contact, containment, and proprioceptive input, (which more closely mimics the uterine environment) and can decrease excitability and promote self-regulation, while also allowing for movement with recoil back to flexion.

干预措施: Dandle Roo/Dandle Wrap (Device)

结局指标

主要结局

NICU Network Neurobehavioral Scale (NNNS)

时间窗: 35 to 41 weeks (term equivalent); prior to NICU discharge

The NNNS wasl used to assess neurobehavioral outcome near term equivalent (between 35 weeks and 41 weeks postmenstrual age). This tool consists of eliciting neonatal reflexes and observing behavior. From the assessment, 13 summary scores were determined for each of the following constructs: habituation (1-9), orientation (1-9), self regulation (1-9), tolerance of handling (0-1), hypertonia (0-10), hypotonia (0-10), asymmetry (0-16), lethargy (0-15), excitability (0-15), sub-optimal reflexes (0-15), arousal (1-9), quality of movement (1-9) and stress (0-1). Each summary score is analyzed for associations with subsequent developmental outcome. A higher score in each category indicates more of that construct. Specifically, for the summary score of asymmetry (the significant finding in this study), higher scores equal more asymmetry.

次要结局

  • The Bayley Scales of Infant Development-3rd Edition (BSID-III)(1 year, 2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Roberta Pineda

Research Assistant Professor

Washington University School of Medicine

研究点 (2)

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