Face Perception and Impact of Surgical Masks in Preterm Infants

Not Applicable

Not yet recruiting

• Conditions: Visual Preference With and Without Mask in Term Infant; Visual Preference With and Without Mask in Preterm Infant
• Interventions: Other: Presentation of differents face pictures

• Registration Number: NCT05790187
• Lead Sponsor: University Hospital, Grenoble

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-02-15
• Study First Submitted QC: 2023-03-27
• Last Update Submitted: 2023-03-27
• Study First Posted: 2023-03-30
• Last Update Posted: 2023-03-30
• Study Start: 2023-04-01
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
visual test	Presentation of differents face pictures	Presentation of differents face pictures

Primary Outcome Measures

Name	Time	Method
proportion of visual fixation time to photos of masked/non-masked faces.	once, at term (at 37 weeks corrected age)	time of picture visual fixation (seconds)