跳至主要内容
临床试验/NCT02908113
NCT02908113Unknown不适用

Sensory Maturation of Preterm Infants: From Visual Sensitivity to Multisensory Perception

University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2015年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
2
主要终点
visual stimulus detection with luminance

研究概览

简要总结

We aim to increase our knowledge of the impact of preterm birth on the maturation of the visual and auditory systems and on the development of multisensory perception

Specifically, we aim to evaluate the preterm infants' capabilities of detection and discrimination of different visual and auditory stimuli according to gestational age, post menstrual age and the duration of the postnatal life.

A secondary aim is to compare this competencies in preterm and full term control art term equivalent age.

The final aim is to optimize the hospital environment in order to make it correspond to the expectations and sensory abilities of very preterm infants.

Our hypothesis is that preterm birth exposes the infants to numerous atypical stimuli which could accelerate the processes of sensory maturation

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
23 Weeks 至 42 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Newborn less than 32 weeks PMA hospitalized in the Hospital of Hautepierre, Strasbourg, France)
  • Consent obtained from both parents
  • Social insurance coverage

排除标准

  • Any known malformation
  • Brain lesions discovered on brain ultrasound (Intra-Ventricular hemorrhage grade III or IV periventricular Leukomalacia).
  • Unstable clinical State
  • Retinopathy Of Prematurity stage> 2 or in zone 1
  • Family history of abnormal color vision.
  • Abnormalities in auditory testing
  • Transfer to another hospital expected before 40 week PMA

研究组 & 干预措施

preterm infants

Other

physiological data collection, behavioral, cerebral hemodynamics, physical environmental newborns studied in response to visual stimuli / auditory or visual-auditory calibrated

干预措施: collection data (Behavioral)

preterm infants

Other

physiological data collection, behavioral, cerebral hemodynamics, physical environmental newborns studied in response to visual stimuli / auditory or visual-auditory calibrated

干预措施: IRM (Behavioral)

term infants

Other

physiological data collection, behavioral, cerebral hemodynamics, physical environmental newborns studied in response to visual stimuli / auditory or visual-auditory calibrated

干预措施: IRM (Behavioral)

term infants

Other

physiological data collection, behavioral, cerebral hemodynamics, physical environmental newborns studied in response to visual stimuli / auditory or visual-auditory calibrated

干预措施: collection data (Behavioral)

结局指标

主要结局

visual stimulus detection with luminance

时间窗: 3 months

in "green" condition in hospital, luminance ( 100 and 300 lux ) and color (blue- red-yellow- white) variables

auditory stimulus detection with parents voice

时间窗: 3 months

use parents voice, pure sound of 500 Hz

次要结局

  • behavioral responsiveness to visual stimuli calibrated collected from video recordings(3 months)

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验