Enhanced Baby Items for Infant Development

Overseen By Elizabeth Simpson, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Birth complications, Preterm birth, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 months

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Enhanced Baby Items for Infant Development?

Research shows that early meaningful auditory experiences, like those provided by reading aloud, can enhance language outcomes and promote cognitive and social-emotional development in infants, suggesting that using LENA audio recorders in infant t-shirts might have similar benefits. ^{1 2 3 4 5}

Is the use of Language Environment Analysis (LENA) audio recorders safe for infants?

A study involving 3-4-year-old children using LENA audio recorders found it feasible to gather data without reporting any safety concerns, suggesting it is generally safe for use in this age group. ^{5 6 7 8 9}

How does the Enhanced Baby Items for Infant Development treatment differ from other treatments for infant motor development?

This treatment is unique because it uses sensorized toys and smart garments to monitor and promote infant motor development in natural play environments, providing real-time feedback and data on infants' physical interactions and positioning, unlike traditional methods that may not offer such detailed insights. ^{10 11 12 13 14}

Research Team

Elizabeth Simpson, Ph.D.

Principal Investigator

University of Miami

Eligibility Criteria

This study is for English-speaking mothers who are at least 28 weeks pregnant or have newborns less than 2 weeks old. The infants must be born full term and healthy, with no known birth complications.

Inclusion Criteria

Mothers and their infants must be healthy with no known birth complications

I am at least 28 weeks pregnant or my baby is less than 2 weeks old.

My baby was born at or after 37 weeks of pregnancy.

Exclusion Criteria

Participants who does not meet all the inclusion criteria.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive baby items (bouncer or carrier) for use from birth up to 8 months

8 months

Follow-up

Participants are monitored for infant development outcomes and parental engagement

8 months

Treatment Details

Interventions

• Baby Bouncer
• Baby Carrier
• Infant t-shirts with Language Environment Analysis (LENA) audio recorders

Trial Overview The trial is testing if baby items like a carrier, infant t-shirts with audio recorders (LENA), and a bouncer can help in the healthy development of infants.

Participant Groups

Group I: Baby Carrier Group with Infant T-Shirt with LENA Experimental Treatment 2 Interventions

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

Group II: Baby Carrier Group Experimental Treatment 1 Intervention

Participants in the group will be receiving a baby carrier for use from infant's birth up to 8 months after birth.

Group III: Baby Bouncer Group with Infant T-Shirt with LENA Experimental Treatment 2 Interventions

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

Group IV: Baby Bouncer Group Experimental Treatment 1 Intervention

Participants in the group will be receiving a baby bouncer for use from infant's birth up to 8 months after birth.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Findings from Research

Early auditory experiences, such as reading aloud in the NICU, significantly enhance language, cognitive, and social-emotional development in high-risk infants.

Implementing a reading-aloud enrichment program in the NICU can strengthen parent-infant relationships and provide a roadmap for improving neurodevelopmental outcomes in these vulnerable infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reading Aloud with Infants in the Neonatal Intensive Care Unit: A Unit-Based Program to Enhance Language Enrichment and Support Early Foundational Relationships. Erdei, C., Klass, P., Inder, TE.[2023]

The intervention tested on clinically stable preterm infants (33-34 weeks postconceptional age) over a 4-day period was found to be safe, with physiological parameters like pulse rate and oxygen saturation remaining within normal limits.

The intervention significantly improved the infants' behavioral state, leading to increased alertness, indicating its potential to positively influence developmental outcomes in preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of physiologic and behavioral response of intermediate care preterm infants to intervention. White-Traut, RC., Nelson, MN., Silvestri, JM., et al.[2007]

References

1. United States pubmed.ncbi.nlm.nih.gov

Developmental care, neonatal behavior and postnatal maternal depressive symptomatology predict internalizing problems at 18 months for very preterm children. [2022]

2. Norway pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of maternal infant-directed reading among hospitalised preterm infants. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Reading Aloud with Infants in the Neonatal Intensive Care Unit: A Unit-Based Program to Enhance Language Enrichment and Support Early Foundational Relationships. [2023]

4. Norway pubmed.ncbi.nlm.nih.gov

Crying behaviour in early infancy is associated with developmental outcome at two years of age in very low birth weight infants. [2008]

5. England pubmed.ncbi.nlm.nih.gov

Ecological momentary assessment of using food to soothe during infancy in the INSIGHT trial. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Patterns of physiologic and behavioral response of intermediate care preterm infants to intervention. [2007]

7. United States pubmed.ncbi.nlm.nih.gov

Noise analysis of three newborn infant isolettes. [2007]

8. United States pubmed.ncbi.nlm.nih.gov

Neonatal intensive care unit incubators reduce language and noise levels more than the womb. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Investigating Cumulative Exposures among 3- to 4-Year-Old Children Using Wearable Ultrafine Particle Sensors and Language Environment Devices: A Pilot and Feasibility Study. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Environmental opportunities questionnaire: development of a measure of the environment supporting early motor development in the first year of life. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Design and development of a sensorized wireless toy for measuring infants' manual actions. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Infant motor development and equipment use in the home. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Design and validation of a smart garment to measure positioning practices of parents with young infants. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Quantifying infant physical interactions using sensorized toys in a natural play environment. [2018]