Infant DevelopmentNCT04267302
Baby Item Learning and Development Study
A study testing Baby Bouncer, Infant t-shirts with Language Environment Analysis (LENA) audio recorders and Baby Carrier in people with Infant Development, run by University of Miami at 1 site in United States.
Trial summary
The goal of this study is to experimentally test whether baby items can promote healthy infant development. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- What is being tested?
- Baby Bouncer, Infant t-shirts with Language Environment Analysis (LENA) audio recorders and Baby Carrier
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2020to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants who does not meet all the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to experimentally test whether baby items can promote healthy infant development.
- Conditions
- Infant Development
- Being tested
- Baby Bouncer, Infant t-shirts with Language Environment Analysis (LENA) audio recorders, Baby Carrier
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby BouncerOther
Fischer Price baby bouncer.
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 CarrierOther
Ergobaby Baby carrier.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Baby Bouncer; Other: 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. Receives: 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. Receives: Other: Infant t-shirts with Language Environment Analysis (LENA) audio recorders; Other: Baby Carrier |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 months
Oxytocin levels
Mother and infant oxytocin levels will be measured via saliva sample.
Measured: 8 months
Percentage of infant and adult vocalizations time
Assessed via 2-8 hours audio recordings on LENA.
Measured: 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.
Measured: 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.
Measured: Up to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start7 Feb 2020
- Primary completion31 May 2023
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Simpson, University of Miami
- Investigators
- Elizabeth Simpson, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267302
- Sponsor's protocol ID
- 20190970
- Status last verified
- May 2026
- First submitted
- 7 Feb 2020
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baby Item Learning and Development Study
- ClinicalTrials.gov ID
- NCT04267302
- Acronym / sponsor ID
- 20190970
- Conditions
- Infant Development
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to experimentally test whether baby items can promote healthy infant development.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Baby Bouncer Group | Other | Other: Baby BouncerParticipants 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 | Other | Other: Baby Bouncer, Other: Infant t-shirts with Language Environment Analysis (LENA) audio recordersA subsample of the participants in the baby bouncer group will also receive infant t-shirts with wearable audio recorders. |
| Baby Carrier Group | Other | Other: Baby CarrierParticipants 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 | Other | Other: Infant t-shirts with Language Environment Analysis (LENA) audio recorders, Other: Baby CarrierA subsample of the participants in the baby carrier group will also receive infant t-shirts with wearable audio recorders. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants who does not meet all the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baby BouncerFischer Price baby bouncer. | Other | Baby Bouncer Group, Baby Bouncer Group with Infant T-Shirt with LENA |
| Infant t-shirts with Language Environment Analysis (LENA) audio recordersInfant t-shirts with wearable LENA audio recorders for 2-8 hours of recordings of vocal interaction, crying and turn-taking. | Other | Baby Bouncer Group with Infant T-Shirt with LENA, Baby Carrier Group with Infant T-Shirt with LENA |
| Baby CarrierErgobaby Baby carrier. | Other | Baby Carrier Group, Baby Carrier Group with Infant T-Shirt with LENA |
Primary outcome
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.
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.
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.
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.
Oxytocin levels
Time frame: 8 months
Mother and infant oxytocin levels will be measured via saliva sample.
Percentage of infant and adult vocalizations time
Time frame: Up to 8 hours
Assessed via 2-8 hours audio recordings on LENA.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Simpson, Ph.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baby Bouncer, Infant t-shirts with Language Environment Analysis (LENA) audio recorders and Baby Carrier in people with Infant Development, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive skill as assessed via eye tracking (time frame: 8 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.