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Sleep Organization in Premature Infants With Feeding Difficulties

Babies born too soon, premature babies, can have complications following birth because their systems are immature. Hospitals help prevent deformities and delays in motor development by using therapeutic positioning to provide containment as they would experience in the womb. They also often have trouble eating. They have discomfort, are irritable, refuse to eat and cry because their digestive system is immature. The neonatal intensive unit can create stress and disrupt their sleep. Going from active to deep sleep is essential for infant brain development, learning and memory formation. Their sleep states early in life predict their developmental outcome. The purpose is to determine whether a conformational positioning system, one that can mold to the baby and contain him or her, will allow more time asleep in premature infants with feeding problems compared to the standard crib mattress. We hypothesize that the number of total sleep time will be longer and the number of arousals out of sleep lower when they are sleeping on the conformational positioning system compared to the mattress.

研究概览

详细说明

Premature infants are at risk for complications due to the immaturity of motor, gastrointestinal, respiratory, cutaneous and behavioral systems. Therapeutic positioning is routinely used to provide containment, maintain a flexed position and prevent skeletal deformities and delays in motor development. Premature infants have feeding difficulties and frequently experience gastroesophageal reflux, discomfort, refusal to feed, irritability, and crying. The neonatal intensive care environment can create stress and disrupts sleep-wake cycles and self-regulatory behaviors. Cycling from active to deep sleep states is required for neurosensory processing, learning, memory formation and brain plasticity. Sleep and waking states for premature infants are predictive of neurodevelopmental outcomes. The purpose of the study is to determine whether the use of conformational positioning will be associated with greater total sleep time in premature infants with a history feeding difficulty compared to positioning on a mattress alone. We hypothesize that the number of arousals and total sleep time will be affected by the support surface. Specifically, the number of arousals will be lower and total sleep time will be greater for infants when they are on a conformational positioning (CP) device compared to when they are on the standard positioning system (mattress) (SP). The use of CP will reduce the number of arousals, increase the total sleep time, and bring about behavioral states that are conducive to regulation of attention, state and motor response relative to SP.

研究类型

介入性

注册 (实际的)

25

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ohio
      • Cincinnati、Ohio、美国、45229
        • Cincinnati Children's Hospital Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

6个月 至 8个月 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Gestational age of < 37 weeks
  • Feeding difficulty due to prematurity or a medical condition
  • Not taking sedative medications for 24 hours before sleep study
  • Post-surgery
  • Sufficiently medically stable to undergo procedures

Exclusion Criteria:

  • Gestational age equal to or greater than 37 weeks
  • Clinical apnea
  • Require mechanical ventilatory support
  • Received sedative medications 24 hours before sleep study
  • Brain injury or neurological condition that limits movement
  • Orthopedic conditions requiring fixed positioning
  • Arthrogryposis
  • Osteogenesis imperfecta
  • Medically unstable such that procedures cannot be tolerated

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:conformational positioner & mattress
conformational positioner & mattress, five hours on each
The conformational positioning system will be compared to the standard infant crib mattress.
其他名称:
  • therapeutic positioner
  • fluidized bed positioner

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Sleep organization defined as efficiency, active sleep time, quiet sleep time, number of arousals, measured by polysomnography
大体时间:Overnight, 10.5 hour standard EEG sleep study
Standard polysomnography electrodes are applied to the subject in the evening and the subject is placed on either the standard mattress or the conformational positioning system (assigned at random) for the first 5 hours. The subject is then moved onto the second treatment for the remainder of the study. EEG measures are recorded continuously over the entire period. The EEG data are assessed by trained sleep study physicians and clinical staff.
Overnight, 10.5 hour standard EEG sleep study

次要结果测量

结果测量
措施说明
大体时间
Sleep state by behavioral observation
大体时间:Two 30-minute periods, one on each treatment, during the EEG sleep study
Nurses trained in the techniques of premature infant behavioral state determination will observe the infant for two 30-minute periods while the EEG sleep study is being conducted. One nurse will observe when the subject is on the standard mattress and the other will observe when the subject is on the conformational positioning system. They will record specific behaviors observed in 2-minute intervals during the 30-minute period.
Two 30-minute periods, one on each treatment, during the EEG sleep study

其他结果措施

结果测量
措施说明
大体时间
Impact of prior surgery on sleep organization
大体时间:Overnight, 10-hour sleep study
Standard polysomnography electrodes are applied to the subject in the evening and the subject is placed on either the standard mattress or the conformational positioning system (assigned at random) for the first 5 hours. The subject is then moved onto the second treatment for the remainder of the study. EEG measures are recorded continuously over the entire period. The EEG data are assessed by trained sleep study physicians and clinical staff. The sleep organization and behaviorally observed sleep state will be compared for the subjects grouped as having had surgery prior to the study or not having had surgery to ascertain the impact of surgery while controlling for the treatment effects.
Overnight, 10-hour sleep study

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Marty O Visscher, PhD、Children's Hospital Medical Center, Cincinnati

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年9月1日

初级完成 (实际的)

2012年7月1日

研究完成 (实际的)

2012年7月1日

研究注册日期

首次提交

2013年9月17日

首先提交符合 QC 标准的

2013年9月18日

首次发布 (估计)

2013年9月19日

研究记录更新

最后更新发布 (实际的)

2020年1月29日

上次提交的符合 QC 标准的更新

2020年1月27日

最后验证

2013年9月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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