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OpenTrials
Active, Not Recruiting

NCT Number: NCT04267302

Baby Item Learning and Development Study

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Infant Development

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33146, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Baby Bouncer

Other

Fischer Price baby bouncer.

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

Other

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

Baby Carrier

Other

Ergobaby Baby carrier.

Primary outcomes

  1. Cognitive skill as assessed via eye tracking

    Time frame: 8 months

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

  2. Parental Engagement

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  5. Oxytocin levels

    Time frame: 8 months

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

  6. Percentage of infant and adult vocalizations time

    Time frame: Up to 8 hours

    Assessed via 2-8 hours audio recordings on LENA.

  7. Percentage of infant and adult turn taking

    Time frame: 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.

  8. Percentage of Infant crying time

    Time frame: Up to 8 hours

    Percentage of infant crying time will be assessed via 2-8 hours audio recordings on LENA.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2027
First posted
Feb 12, 2020
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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