Face Perception and Impact of Surgical Masks in Preterm Infants

NCT05790187 | Unknown

• 1 other identifier: 38RC22.0365
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  time of picture visual fixation (seconds)

  once, at term (at 37 weeks corrected age)

Study Arms (1)

visual test

EXPERIMENTAL

Presentation of differents face pictures

Other: Presentation of differents face pictures

Interventions

Presentation of differents face pictures OTHER

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

visual test

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Laboratoire de Psychologie et NeuroCognition: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 30, 2023
• Study Start: April 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: March 30, 2023

Record last verified: 2023-01