Active Not Recruiting
NA
INTERVENTIONAL
NCT04267302
Baby Item Learning and Development Study
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The goal of this study is to experimentally test whether baby items can promote healthy infant development.
Interventions
Name:
Baby Bouncer
Type:
OTHER
Description:
Fischer Price baby bouncer.
Name:
Infant t-shirts with Language Environment Analysis (LENA) audio recorders
Type:
OTHER
Description:
Infant t-shirts with wearable LENA audio recorders for 2-8 hours of recordings of vocal interaction, crying and turn-taking.
Name:
Baby Carrier
Type:
OTHER
Description:
Ergobaby Baby carrier.
Primary Outcomes
Measure:
Cognitive skill as assessed via eye tracking
TimeFrame:
8 months
Description:
Cognitive skill is reported as the percentage of accuracy of eye gaze as evaluated via the eye tracking procedure.
Measure:
Parental Engagement
TimeFrame:
8 months
Description:
Mother and infant will engage in a 15-minute unstructured free playtime. This engagement will be videotaped and assessed by the Investigator. Parental engagement is reported as the percentage of parental sensitivity and synchrony scored on a 0-100% scale with the higher score indicating increased sensitivity and synchrony.
Measure:
Infant Reactivity (Crying) assessed by the Face to Face/Still Face Procedure
TimeFrame:
8 months
Description:
Infant emotions and social engagement is reported as the time noted when the infant was crying during the 6 minute Face to Face/Still Face Procedure.
Measure:
Infant Reactivity (Smiling) assessed by the Face to Face/Still Face Procedure
TimeFrame:
8 months
Description:
Infant emotions and social engagement is reported as the time noted when the infant was smiling during the 6 minute Face to Face/Still Face Procedure.
Measure:
Oxytocin levels
TimeFrame:
8 months
Description:
Mother and infant oxytocin levels will be measured via saliva sample.
Measure:
Percentage of infant and adult vocalizations time
TimeFrame:
Up to 8 hours
Description:
Assessed via 2-8 hours audio recordings on LENA.
Measure:
Percentage of infant and adult turn taking
TimeFrame:
Up to 8 hours
Description:
Assessed via 2-8 hours audio recordings on LENA. Turn taking is defined as the verbal exchange by adult and infant.
Measure:
Percentage of Infant crying time
TimeFrame:
Up to 8 hours
Description:
Percentage of infant crying time will be assessed via 2-8 hours audio recordings on LENA.
Trial Information
NCT ID
NCT04267302
Status
Active Not Recruiting
Study Type
INTERVENTIONAL
Phases
NA
Sponsor
University of Miami
Last Updated
December 15, 2025