NewbornBABYMASKNCT05109481
Masks and Visual Preferences in the Newborn
An observational study of Newborn and Vision, Ocular, run by University Hospital, Grenoble.
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. Read more about this study
- Who is it for?
- Ages 24 hours to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Newborn, Vision, Ocular, Masks
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2021to 15 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 hours to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: 200 healthy newborn born between September 2021 ans September 2021
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Mathilde Fort, MD, PhD contact
About this study
Official title: 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.
Read more
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.
Read the detailed 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.
- Conditions
- Newborn, Vision, Ocular, Masks
- Keywords
- Neonatology
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of fixation of the newborn's gaze on an image
Time of fixation of the newborn's gaze on an image
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start15 Nov 2021 (estimated)
- Primary completion15 Nov 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire de Psychologie et NeuroCognition
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109481
- Sponsor's protocol ID
- 2021-A01711-40
- Acronym
- BABYMASK
- Status last verified
- Sep 2021
- First submitted
- 22 Sep 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF IMPACT OF THE MASK ON THE VISUAL PREFERENCES OF THE NEWBORN
- ClinicalTrials.gov ID
- NCT05109481
- Acronym / sponsor ID
- BABYMASK / 2021-A01711-40
- Conditions
- Newborn, Vision, Ocular, Masks
- Keywords
- Neonatology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Laboratoire de Psychologie et NeuroCognition
- Study start
- 15 Nov 2021 (estimated)
- Primary completion
- 15 Nov 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 24 hours to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 200 healthy newborn born between September 2021 ans September 2021
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time of fixation of the newborn's gaze on an image
Time frame: One year
Time of fixation of the newborn's gaze on an image
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathilde Fort, MD, PhD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Newborn and Vision, Ocular, run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie chevallier, MD, PhD (0476765577, mchevallier3@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of fixation of the newborn's gaze on an image (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.