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Face Perception and Impact of Surgical Masks in Preterm Infants (Premask)

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Presentation of differents face pictures
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Visual Preference With and Without Mask in Term Infant

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    visual test

    Arm Description

    Presentation of differents face pictures

    Outcomes

    Primary Outcome Measures

    proportion of visual fixation time to photos of masked/non-masked faces.
    time of picture visual fixation (seconds)

    Secondary Outcome Measures

    Full Information

    First Posted
    February 15, 2023
    Last Updated
    March 27, 2023
    Sponsor
    University Hospital, Grenoble
    Collaborators
    Laboratoire de Psychologie et NeuroCognition
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05790187
    Brief Title
    Face Perception and Impact of Surgical Masks in Preterm Infants
    Acronym
    Premask
    Official Title
    Face Perception and Impact of Surgical Masks in Preterm Infants
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    April 1, 2024 (Anticipated)
    Study Completion Date
    April 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Grenoble
    Collaborators
    Laboratoire de Psychologie et NeuroCognition

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Visual Preference With and Without Mask in Term Infant, Visual Preference With and Without Mask in Preterm Infant

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    visual test
    Arm Type
    Experimental
    Arm Description
    Presentation of differents face pictures
    Intervention Type
    Other
    Intervention Name(s)
    Presentation of differents face pictures
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    proportion of visual fixation time to photos of masked/non-masked faces.
    Description
    time of picture visual fixation (seconds)
    Time Frame
    once, at term (at 37 weeks corrected age)

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: 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)

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Face Perception and Impact of Surgical Masks in Preterm Infants

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