Baby Item Learning and Development Study

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

Study Overview

• Status: Active, not recruiting
• Conditions: Infant Development
• Intervention / Treatment: Other: Baby Bouncer; Other: Infant t-shirts with Language Environment Analysis (LENA) audio recorders; Other: Baby Carrier

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33146
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Baby Bouncer Group; Participants in the group will be receiving a baby bouncer for use from infant's birth up to 8 months after birth.	Other: Baby Bouncer; Fischer Price baby bouncer.
Other: Baby Bouncer Group with Infant T-Shirt with LENA; A subsample of the participants in the baby bouncer group will also receive infant t-shirts with wearable audio recorders.	Other: Baby Bouncer; Fischer Price baby bouncer.; Other: Infant 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.
Other: Baby Carrier Group; Participants in the group will be receiving a baby carrier for use from infant's birth up to 8 months after birth.	Other: Baby Carrier; Ergobaby Baby carrier.
Other: Baby Carrier Group with Infant T-Shirt with LENA; A subsample of the participants in the baby carrier group will also receive infant t-shirts with wearable audio recorders.	Other: Infant 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.; Other: Baby Carrier; Ergobaby Baby carrier.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	8 months
Oxytocin levels	Mother and infant oxytocin levels will be measured via saliva sample.	8 months
Percentage of infant and adult vocalizations time	Assessed via 2-8 hours audio recordings on LENA.	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.	Up to 8 hours
Percentage of Infant crying time	Percentage of infant crying time will be assessed via 2-8 hours audio recordings on LENA.	Up to 8 hours

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Elizabeth Simpson, Ph.D., University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2020
• Primary Completion (Actual): May 31, 2023
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20190970

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No