Baby Item Learning and Development Study

Infant Development Clinical Trial

Official title:

Baby Item Learning and Development Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04267302
• Other study ID #: 20190970
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 7, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Infant Development

Intervention

Other:
• Baby Bouncer
Fischer Price baby bouncer.
• 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.
• Baby Carrier
Ergobaby Baby carrier.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Oxytocin levels	Mother and infant oxytocin levels will be measured via saliva sample.	8 months
Primary	Percentage of infant and adult vocalizations time	Assessed via 2-8 hours audio recordings on LENA.	Up to 8 hours
Primary	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
Primary	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