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Masks and Visual Preferences in the Newborn (BABYMASK)

2021年11月3日 更新者:University Hospital, Grenoble

EVALUATION OF IMPACT OF THE MASK ON THE VISUAL PREFERENCES OF THE NEWBORN

What impact can facial masks have on face exploration in the first few weeks of life? No study has yet investigated this. The objective of our study was to evaluate the impact of the mask on the face processing (preferential gaze, visual recognition) of the term infant for familiar (e.g. mother's face) and unfamiliar (stranger's face) faces.

This is a prospective study which will take place in Grenoble Maternity Hospital.

200 newborns will be enrolled between 24 hours and 7 days of life during one year. Different pairs of images will be presented on a screen while an experimenter records the infant's gaze. On each trial, the experimenter will judge when the infant is looking at the screen or not and assess when 10 seconds of screen gaze time has been accumulated.

The comparisons will be made to determine whether statistically, one face is looked at significantly longer than another.

研究概览

地位

尚未招聘

详细说明

Background Since March 2020, the mask has invaded the everyday life of families, workplaces and hospitals. In contrast to the pre-Covid era, healthy newborns in their first days of life are now exposed to the faces of adults wearing masks. Yet early visual experience of newborns with faces is crucial, as it will set the stage for early communication .For example, a systematic preference for human faces exists in newborns .However, this system is not limited to a preferential orientation; it has been shown that the newborn recognises faces during the first week of life .

Maternal recognition is particularly important for the development of attachment and emotional interactions. Several studies have shown that 2-3 day old infants recognize their mother's face (real, in vivo) despite relatively limited visual acuity .However, no study has been able to show the same on the basis of photographs (without other sensory stimuli), such as the mother's smell.

Objective The aim of this study is to measure the impact that these masks can have on the exploration of known (mother) and unknown faces in the first weeks of life. No study has so far investigated this.

Methods Study This is a prospective, single-centre study.

Population The newborns included will be newborns between 24 hours and 7 days of life before discharge from the maternity hospital, born at term (37 weeks of gestational age) at the Grenoble University Hospital, whose parents speak French, are beneficiaries of social security, and did not object to participating in the study. Newborns with a pathology requiring or having required examinations, hospitalisation or other during the first 24 hours, which could have impacted on the exposure of the newborn to the mask or parents suffering from Covid during the maternity stay will not be included in the study.

Protocol For a newborn, each test will take place between 24 hours and discharge from the maternity hospital (generally <7 days) for a newborn. Concerning the test: the newborns are installed on the mother's, facing the computer screen above which is positioned the experimenter in charge of recording the infants' gaze. The screen is positioned 30 cm from the newborns' face, a distance appropriate to their poor visual acuity.

The investigators are going to carry out visual preference tests. This involves pairs of images presented on the screen while an experimenter records the infant's gaze. On each trial, the experimenter will judge when the infant is looking at the screen or not and assess when 10 seconds of screen time has been accumulated.

Ideally, a newborn should be able to do a series of trials, but as their attention fluctuates according to the time of day and from one individual to another, it is possible that some children may only do one trial.

Statistical analysis A minimum of 30 participants per test will be required. As not all infants tested can be included in our study, because they are likely to fall asleep, become restless or exhibit maladaptive behaviour (approximately 30%), the invetigators will test 200 children for the 5 tests. The behavioural data consist of gaze times on stimuli during a presentation period. The behavioural data consist of gaze times on stimuli during a presentation period. These gaze times are obtained by manually scanning the videos. Comparisons of the mean of the proportions of gaze times to each image will be made with parametric tests (Student's t test, analysis of variance or mixed models if n = 30 in each test) or non-parametric tests (Chi-2, if n < 30 in each group) in order to determine whether statistically, one face is gazed at significantly longer than another. Using Gpower software, a moderate effect size was estimated for a sample of 20 newborns (estimated statistical power of 0.8).

Expected results Our hypothesis and clinical impression is that the mask has an impact on the visual exploration of the neonate. The investigators expect that the effects will also be modulated by the neonate's visual experience with the mask but also by the information requested in the "mask exposition" questionnaire. Indeed, these characteristics may influence the newborn's experience with masked and unmasked faces, as well as the quality of mother-infant interactions.

研究类型

观察性的

注册 (预期的)

200

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。

学习联系方式

研究联系人备份

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

1天 至 1周 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

200 healthy newborn born between September 2021 ans September 2021

描述

Inclusion Criteria:

  • newborns between 24 hours and 7 days of life before discharge from the maternity hospital,
  • born at term (37 weeks of gestational age) at the Grenoble University Hospital,
  • whose parents speak French
  • whose parents are beneficiaries of social security
  • whose parents did not object to participating in the study.

Exclusion Criteria:

Newborns with

  • a pathology requiring or having required examinations,
  • a hospitalisation or other during the first 24 hours, which could have impacted on the exposure of the newborn to the mask
  • parents suffering from Covid during the maternity stay will not be included in the study.

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

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
Time of fixation of the newborn's gaze on an image
大体时间:One year
Time of fixation of the newborn's gaze on an image
One year

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。

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 (预期的)

2021年11月15日

初级完成 (预期的)

2022年11月15日

研究完成 (预期的)

2022年12月15日

研究注册日期

首次提交

2021年9月22日

首先提交符合 QC 标准的

2021年11月3日

首次发布 (实际的)

2021年11月5日

研究记录更新

最后更新发布 (实际的)

2021年11月5日

上次提交的符合 QC 标准的更新

2021年11月3日

最后验证

2021年9月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 2021-A01711-40

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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