CClinicalTrials.gg
Status unknownNCT05790187PremaskUpdated Mar 30, 2023

Face Perception and Impact of Surgical Masks in Preterm Infants

An interventional study of Presentation of differents face pictures in Visual Preference With and Without Mask in Term Infant and Visual Preference With and Without Mask in Preterm Infant, sponsored by University Hospital, Grenoble. Status unknown. Per ClinicalTrials.gov, last updated 2023-03-30.

Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Sex
All
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Study summary

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.

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Conditions studied

  • Visual Preference With and Without Mask in Term Infant
  • Visual Preference With and Without Mask in Preterm Infant

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In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's planned enrollment of 120 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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 exclusion criteria will not be eligible for inclusion in the study.

Exclusion criteria

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)
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    visual test

    Presentation of differents face pictures

    Other: Presentation of differents face pictures

Interventions

  • OtherPresentation of differents face pictures

    Test 1: Unmasked face vs. masked face Test 2: Unmasked face up vs. unmasked face down Test 3: Face masked right side vs. face masked reverse

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What researchers measure

Primary outcomes

  1. proportion of visual fixation time to photos of masked/non-masked faces.

    time of picture visual fixation (seconds)

    Time frame: once, at term (at 37 weeks corrected age)

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05790187
Lead sponsor
University Hospital, Grenoble
Collaborators
Laboratoire de Psychologie et NeuroCognition
Responsible party
Sponsor
First posted
Mar 30, 2023
Start date
Apr 1, 2023 (estimated)
Primary completion
Apr 1, 2024 (estimated)
Completion
Apr 1, 2024 (estimated)
Last update
Mar 30, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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