Baby Item Learning and Development Study

Not Applicable

Active, not recruiting

• Conditions: Infant Development
• Interventions: Other: Baby Carrier; Other: Baby Bouncer; Other: Infant t-shirts with Language Environment Analysis (LENA) audio recorders

• Registration Number: NCT04267302
• Lead Sponsor: University of Miami

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-07
• Study First Submitted: 2020-02-07
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-12
• Primary Completion: 2023-05-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Baby Carrier Group	Baby Carrier	Participants in the group will be receiving a baby carrier for use from infant's birth up to 8 months after birth.
Baby Carrier Group with Infant T-Shirt with LENA	Baby Carrier	A subsample of the participants in the baby carrier group will also receive infant t-shirts with wearable audio recorders.
Baby Bouncer Group	Baby Bouncer	Participants in the group will be receiving a baby bouncer for use from infant's birth up to 8 months after birth.
Baby Bouncer Group with Infant T-Shirt with LENA	Infant t-shirts with Language Environment Analysis (LENA) audio recorders	A subsample of the participants in the baby bouncer group will also receive infant t-shirts with wearable audio recorders.
Baby Bouncer Group with Infant T-Shirt with LENA	Baby Bouncer	A subsample of the participants in the baby bouncer group will also receive infant t-shirts with wearable audio recorders.
Baby Carrier Group with Infant T-Shirt with LENA	Infant t-shirts with Language Environment Analysis (LENA) audio recorders	A subsample of the participants in the baby carrier group will also receive infant t-shirts with wearable audio recorders.

Primary Outcome Measures

Name	Time	Method
Infant Reactivity (Smiling) assessed by the Face to Face/Still Face Procedure	8 months	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.
Parental Engagement	8 months	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.
Percentage of Infant crying time	Up to 8 hours	Percentage of infant crying time will be assessed via 2-8 hours audio recordings on LENA.
Cognitive skill as assessed via eye tracking	8 months	Cognitive skill is reported as the percentage of accuracy of eye gaze as evaluated via the eye tracking procedure.
Infant Reactivity (Crying) assessed by the Face to Face/Still Face Procedure	8 months	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.
Oxytocin levels	8 months	Mother and infant oxytocin levels will be measured via saliva sample.
Percentage of infant and adult vocalizations time	Up to 8 hours	Assessed via 2-8 hours audio recordings on LENA.
Percentage of infant and adult turn taking	Up to 8 hours	Assessed via 2-8 hours audio recordings on LENA. Turn taking is defined as the verbal exchange by adult and infant.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States