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临床试验/NCT06664749
NCT06664749已完成不适用

Comparison of the Effects of Three Stair Positioning Pillows and Positioning Materials on the Sleep-Wakefulness Status of Preterm Infants

Harran University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年2月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Sleep

研究概览

简要总结

This study was conducted to compare the effectiveness of three stair positioning pillows and positioning materials on the sleep-wakefulness status of preterm infants.

详细描述

It is known that newborns have similar brain activity in the intrauterine period and REM sleep activity, and they sleep more than adults and spend most of their sleep in the REM sleep period. Therefore, sleep quality in the newborn period is directly related to healthy development. Providing a developmentally supportive position in neonatal intensive care units (NICU) is necessary not only for neuromotor and musculoskeletal development, but also for physiological function and stability, thermal regulation, bone density, neurobehavioral organization, calmness and comfort, skin integrity, optimal musculoskeletal development, facilitation of sleep, growth and brain development. Excessive noise in the NICU, prolonged bright lights, separation from the mother, frequent invasive procedures and pain experience are among the factors that disrupt, shorten and create stress in the sleep duration of preterm babies. It is very important to support the sleep of preterm babies in the NICU in order to improve their growth and development, especially their brain development. It is known that therapeutic positions, which are one of the individualized developmental care practices, are effective on sleep.This study was conducted to compare the effectiveness of three stair positioning pillows and positioning materials on the sleep-wakefulness status of preterm infants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
30 Weeks 至 34 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm infants who were postmenstrual age ≥30 and ≤34,
  • had an appropriate weight for gestational age (AGA),
  • were spontaneously breathing (extubated and not receiving any oxygen support),
  • had no history of previous intubation, routinely had caffeine in their diet, and
  • whose parents volunteered to participate in the study were included in the study.

排除标准

  • Preterm infants who were <30 and >34 years postmenstrual,
  • had bradycardia,
  • received an analgesic 4 hours before that could affect sleep,
  • had sepsis,
  • congenital anomalies,
  • intracranial hemorrhage,
  • hyperbilirubinemia,
  • hypoglycemia,
  • underwent surgery,
  • received any oxygen support, or were on mechanical ventilation were excluded from the study.

结局指标

主要结局

Sleep

时间窗: 3 hours

Measured with an actigraphy device. Unit is minutes.

wakefulness

时间窗: 3 hours

Measured with an actigraphy device. Unit is minutes.

次要结局

未报告次要终点

研究者

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

Fatma BOZDAG

Associate Professor

Harran University

研究点 (2)

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