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Baby Item Learning and Development Study

Baby Item Learning and Development Study

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04267302
Enrollment
100
Registered
2020-02-12
Start date
2020-02-07
Completion date
2026-12-31
Last updated
2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant Development

Brief summary

The goal of this study is to experimentally test whether baby items can promote healthy infant development.

Interventions

OTHERBaby Bouncer

Fischer Price baby bouncer.

OTHERInfant t-shirts with Language Environment Analysis (LENA) audio recorders

Infant t-shirts with wearable LENA audio recorders for 2-8 hours of recordings of vocal interaction, crying and turn-taking.

Ergobaby Baby carrier.

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Mothers and their infants must be healthy with no known birth complications * Infants must be born full term (at least 37 weeks gestation) * Mother must speak English * Mothers must be at least 28 weeks along in their pregnancy. Mothers with newborns who are less than 2 weeks will be included.

Exclusion criteria

* Participants who does not meet all the inclusion criteria.

Design outcomes

Primary

MeasureTime frameDescription
Cognitive skill as assessed via eye tracking8 monthsCognitive skill is reported as the percentage of accuracy of eye gaze as evaluated via the eye tracking procedure.
Parental Engagement8 monthsMother 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.
Infant Reactivity (Crying) assessed by the Face to Face/Still Face Procedure8 monthsInfant 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.
Infant Reactivity (Smiling) assessed by the Face to Face/Still Face Procedure8 monthsInfant 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.
Oxytocin levels8 monthsMother and infant oxytocin levels will be measured via saliva sample.
Percentage of infant and adult vocalizations timeUp to 8 hoursAssessed via 2-8 hours audio recordings on LENA.
Percentage of infant and adult turn takingUp to 8 hoursAssessed via 2-8 hours audio recordings on LENA. Turn taking is defined as the verbal exchange by adult and infant.
Percentage of Infant crying timeUp to 8 hoursPercentage of infant crying time will be assessed via 2-8 hours audio recordings on LENA.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026