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临床试验/NCT04314440
NCT04314440Unknown不适用

Cognitive Processing in Preterm Infants and NICU Music Therapy

Saskatchewan Health Authority - Regina Area1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
102
试验地点
1
主要终点
Time looking at a familiar stimulus

研究概览

简要总结

Several positive physiological and behavioural outcomes have been observed in preterm infants exposed to music therapy during their stay at Neonatal Intensive Care Units (NICU). There is ample evidence in the literature showing that brief exposure to music can lead to superior performance on a host of cognitive tasks in laboratory settings in children, adolescent and adults. However, till date no study has examined the cognitive benefits of NICU music therapy in preterm infants. Further habituation tests have been employed to examine cognitive functioning in infants in laboratory setting but the same test have not been employed as a measure to examine early cognitive functioning in preterm infants.

This project will be carried out to examine the benefits of NICU music therapy on the cognitive functioning of preterm infants born at 27- 33 weeks of gestational age. A randomized controlled research design will be employed to compare cognitive functioning between the treatment and control group at 18 - 24 months of corrected gestational age. The treatment group will be exposed to music therapy during their stay in NICU and the controlled group will be exposed to all standardized care available at our institution except music therapy. Habituation tests will be used to examine cognitive functioning of the preterm infants in groups at 18 - 24 months of gestational age.

详细描述

Following previous research, our hypothesis is that infants in the experimental group will display significantly more positive scores on a collection of physiological and behavioural measurements. The stimuli used at each age will be targeted to the infants' developmental level. Bayley Scales of Infant Development will also be administered at 18 - 24 months as part of high risk infant follow up. These data will be included in the analysis for outcome measurement. While seated in a high-chair or their parent's lap, infants will be habituated to a series of images of a particular shape (e.g., a triangle), while their looking time to each stimulus is measured. Each image during habituation will be a unique token of the category (i.e., all different triangles). Habituation will be individually determined, and defined as cumulative looking across three successive trials that is 50% than cumulative looking across the first three trials. Following habituation, infants will be shown a novel token of the habituation shape (e.g., a new triangle) and a novel shape (e.g., a square), in counterbalanced order. If infants recognize the category change, they should look longer at novel category compared to the novel token. For each test, two dependent measures will be sampled: rate of habituation and amount of dishabituation to the novel category. Mixed ANOVA and paired t-tests will be used to analyze the data. As preterm infants have been shown to be delayed on these kinds of tasks, we hypothesize that the experimental group will habituate to each category faster, and/or display stronger dishabituation scores compared to the preterm. We will also use multiple regression analyses to examine relations between the NICU physiological and behavioural measures and the cognitive measures. We hypothesize that infants who most strongly benefited from their therapies in the NICU will display the most advanced cognitive abilities. An intention-to-treat- analysis will be performed for cognitive measures as well. The cognitive assessment at 2 and 4 months that were to be carried out at the Developmental Lab at University of Regina is now canceled due to feasibility concerns.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

年龄范围
27 Weeks 至 33 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Gestation age 27-33 weeks (maternal dates or early fetal ultrasound)
  • Is not on ventilators
  • Written informed consent forms has been signed from the infant's legal guardian

排除标准

  • Infants with congenital abnormalities
  • Severe intraventricular hemorrhage, with ventriculomegaly or parenchymal hemorrhage
  • Infants with known or suspected prenatal exposure to substance
  • Infants receiving palliative care at NICU
  • Infants who are on ventilators
  • Infants whose legal guardian did not sign the consent forms

结局指标

主要结局

Time looking at a familiar stimulus

时间窗: 18 - 24 months

Average difference in rate of habituation as measure by the time looking at a familiar stimulus in mili-seconds between experimental and control groups.

次要结局

  • Physiological measure(15 minutes,before, during, after music therapy, 6 days a week)
  • Behavioral measure(Before to after music therapy 6 days a week)

研究者

发起方
Saskatchewan Health Authority - Regina Area
申办方类型
Other
责任方
Sponsor

研究点 (1)

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