Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05109481 |
| Other study ID # |
2021-A01711-40 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 15, 2021 |
| Est. completion date |
December 15, 2022 |
Study information
| Verified date |
September 2021 |
| Source |
University Hospital, Grenoble |
| Contact |
Marie chevallier, MD, PhD |
| Phone |
0476765577 |
| Email |
mchevallier3[@]chu-grenoble.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.
