Face Perception and Impact of Surgical Masks in Preterm I... | NCT05790187

Studies
Face Perception and Impact of Surgical Masks in Preterm Infants

NCT05790187

Sponsor

University Hospital, Grenoble

Status

Unknown status

Last Update Posted

Mar 30, 2023Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

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

Interventions

Presentation of differents face pictures

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2023Estimated

Primary Completion Date

Apr 1, 2024Estimated

Completion Date

Apr 1, 2024Estimated

First Submitted Date

Feb 15, 2023

First Submission Date that Met QC Criteria

Mar 27, 2023

First Posted Date

Mar 30, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2023

Last Update Posted Date

Mar 30, 2023Actual

Name	Class
Laboratoire de Psychologie et NeuroCognition	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
visual test	Experimental	Presentation of differents face pictures	Other: Presentation of differents face pictures

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided