Baby Item Learning and Development Study

N/AActive Not RecruitingNCT04267302

University of Miami100 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

100

Conditions

Infant Development

Interventions

Baby BouncerOTHER

Fischer Price baby bouncer.

Infant t-shirts with Language Environment Analysis (LENA) audio recordersOTHER

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

Baby CarrierOTHER

Ergobaby Baby carrier.

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

Cognitive skill as assessed via eye tracking

Cognitive skill is reported as the percentage of accuracy of eye gaze as evaluated via the eye tracking procedure.

Time frame: 8 months

Parental Engagement

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.

Time frame: 8 months

Infant Reactivity (Crying) assessed by the Face to Face/Still Face Procedure

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.

Time frame: 8 months

Infant Reactivity (Smiling) assessed by the Face to Face/Still Face Procedure

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.

Time frame: 8 months

Oxytocin levels

Mother and infant oxytocin levels will be measured via saliva sample.

Time frame: 8 months

Percentage of infant and adult vocalizations time

Assessed via 2-8 hours audio recordings on LENA.

Time frame: Up to 8 hours

Percentage of infant and adult turn taking

Assessed via 2-8 hours audio recordings on LENA. Turn taking is defined as the verbal exchange by adult and infant.

Time frame: Up to 8 hours

Data from ClinicalTrials.gov

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