NCT05790187尚未招募不适用
Face Perception and Impact of Surgical Masks in Preterm Infants
University Hospital, Grenoble0 个研究点目标入组 120 人开始时间: 2023年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- proportion of visual fixation time to photos of masked/non-masked faces.
研究概览
简要总结
The preferences to masked and unmasked faces is relevant for premature newborns, since Covid-19, most of the faces that surround them during their hospitalization are masked. The Premask project is a continuation of the InfantMask and BabyMask studies (concerning infant and newborn), by studying the visual preferences to masked and unmasked faces of premature newborns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All preterm infants born before 32SA arriving at term (at≥37SA) hospitalized in the neonatology department of the pediatric hospital of Grenoble and approaching discharge will be included.
- •Of the potential participants meeting the inclusion criteria, those with at least 1 of the following
排除标准
- •will not be eligible for inclusion in the study.
- •Exclusion Criteria:
- •Parents not fluent in French
- •Parents with no social security rights
- •Patient with a syndromic disorder
- •Abnormal neurological examination Invasive or non-invasive ventilation at the time of testing of babies requiring, at the time of testing at ≥37SA, non-invasive or invasive ventilatory support as well as labeled syndromic or ophthalmologic disease of prematurity (retinopathies).
- •Infection requiring isolation
- •Ophthalmologic impairment of prematurity (retinopathy)
结局指标
主要结局
proportion of visual fixation time to photos of masked/non-masked faces.
时间窗: once, at term (at 37 weeks corrected age)
time of picture visual fixation (seconds)
次要结局
未报告次要终点
研究者
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