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

Grenoble Alpes University Hospital Center (CHU) logo

Grenoble Alpes University Hospital Center (CHU)

Status

Not yet enrolling

Conditions

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

Treatments

Other: Presentation of differents face pictures

Study type

Interventional

Funder types

Other

Identifiers

NCT05790187
38RC22.0365

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Volunteers

No 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)

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

120 participants in 1 patient group

visual test
Experimental group
Description:
Presentation of differents face pictures
Treatment:
Other: Presentation of differents face pictures

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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