NCT04267302

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Feb 2020Dec 2026

First Submitted

Initial submission to the registry

February 7, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

February 7, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 12, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

3.3 years

First QC Date

February 7, 2020

Last Update Submit

May 16, 2025

Conditions

Infant Development

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (4)

Baby Bouncer Group

OTHER

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

Baby Bouncer Group with Infant T-Shirt with LENA

OTHER

A subsample of the participants in the baby bouncer group will also receive infant t-shirts with wearable audio recorders.

Other: Baby BouncerOther: Infant t-shirts with Language Environment Analysis (LENA) audio recorders

Baby Carrier Group

OTHER

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

Baby Carrier Group with Infant T-Shirt with LENA

OTHER

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 recordersOther: Baby Carrier

Interventions

Baby BouncerOTHER

Fischer Price baby bouncer.

Baby Bouncer GroupBaby Bouncer Group with Infant T-Shirt with LENA
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 Bouncer Group with Infant T-Shirt with LENABaby Carrier Group with Infant T-Shirt with LENA
Baby CarrierOTHER

Ergobaby Baby carrier.

Baby Carrier GroupBaby Carrier Group with Infant T-Shirt with LENA

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33146, United States

Location

Study Officials

  • Elizabeth Simpson, Ph.D.

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 7, 2020

First Posted

February 12, 2020

Study Start

February 7, 2020

Primary Completion

May 31, 2023

Study Completion (Estimated)

December 31, 2026

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)