Masks and Visual Preferences in the Newborn

NCT05109481 | Unknown

• 1 other identifier: 2021-A01711-40
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

What impact can facial masks have on face exploration in the first few weeks of life? No study has yet investigated this. The objective of our study was to evaluate the impact of the mask on the face processing (preferential gaze, visual recognition) of the term infant for familiar (e.g. mother's face) and unfamiliar (stranger's face) faces. This is a prospective study which will take place in Grenoble Maternity Hospital. 200 newborns will be enrolled between 24 hours and 7 days of life during one year. Different pairs of images will be presented on a screen while an experimenter records the infant's gaze. On each trial, the experimenter will judge when the infant is looking at the screen or not and assess when 10 seconds of screen gaze time has been accumulated. The comparisons will be made to determine whether statistically, one face is looked at significantly longer than another.

Conditions

Newborn; Vision, Ocular; Masks

Keywords

Neonatology

Outcome Measures

Primary Outcomes (1)

• Time of fixation of the newborn's gaze on an image

  Time of fixation of the newborn's gaze on an image

  One year

Eligibility Criteria

• Age: 24 Hours - 7 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

200 healthy newborn born between September 2021 ans September 2021

You may qualify if:

• newborns between 24 hours and 7 days of life before discharge from the maternity hospital,
• born at term (37 weeks of gestational age) at the Grenoble University Hospital,
• whose parents speak French
• whose parents are beneficiaries of social security
• whose parents did not object to participating in the study.

You may not qualify if:

• Newborns with
• a pathology requiring or having required examinations,
• a hospitalisation or other during the first 24 hours, which could have impacted on the exposure of the newborn to the mask
• parents suffering from Covid during the maternity stay will not be included in the study.

Sponsors & Collaborators

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

Central Study Contacts

Marie chevallier, MD, PhD

CONTACT

0476765577; mchevallier3@chu-grenoble.fr

Mathilde Fort, MD, PhD

CONTACT

mathilde.fort@univ-grenoble-alpes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: November 5, 2021
• Study Start: November 15, 2021
• Primary Completion: November 15, 2022
• Study Completion: December 15, 2022
• Last Updated: November 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share