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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether certain baby items can support healthy infant development. It examines the impact of using a baby bouncer or a baby carrier, with some infants also wearing t-shirts fitted with Language Environment Analysis (LENA) audio recorders to track language exposure. The trial seeks healthy mothers and their full-term newborns. Mothers must speak English and either be at least 28 weeks pregnant or have a newborn less than 2 weeks old. Participants will use these items from birth until the baby is 8 months old. As an unphased trial, this study offers mothers a unique opportunity to contribute to understanding infant development and language exposure.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study linked baby bouncers to some safety concerns. Rare reports of serious injuries include one fatal case. Although uncommon, careful use of these products is important.

For baby carriers, research has shown that incorrect use can cause injuries like falls or hip problems. Most injuries occur when the baby is very young, but correct use can help prevent these issues.

Other studies have used Infant t-shirts with LENA audio recorders with older children. These studies found no safety concerns, suggesting they are generally safe to use.

Overall, while these items carry some risks, proper use is key to keeping babies safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these baby development tools because they offer innovative ways to enhance infant growth and learning. Unlike traditional baby products, these items incorporate advanced features like Language Environment Analysis (LENA) audio recorders embedded in infant t-shirts. This unique technology helps track and analyze the baby's language exposure, offering insights into their early cognitive environment. By integrating these features into everyday baby items like bouncers and carriers, the trial aims to explore how such enhancements can positively impact infant development during crucial early months.

What evidence suggests that this trial's treatments could be effective for infant development?

This trial will compare different baby items for infant development. Research has shown that baby bouncers, which participants in the Baby Bouncer Group may receive, support muscle growth, motor skills, and sensory development. Studies have also found that they aid in visual stimulation, balance, and coordination. Meanwhile, baby carriers, which participants in the Baby Carrier Group may receive, strengthen the bond between parent and child, calm babies, support breastfeeding, enhance emotional development, and improve hip joint growth in infants. Additionally, some participants in both groups will receive infant t-shirts with LENA audio recorders. The LENA tool assesses language skill development, helping parents support their child's growth. ^{2 6 7 8 9}

Who Is on the Research Team?

Elizabeth Simpson, Ph.D.

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5703622/

The Effect of Baby Walker on Child Development Some researchers have claimed they can cause developmental delay. We aimed to investigate their effect on child development through a systematic review.

2. hazelandfawn.com hazelandfawn.com/blogs/blog/the-science-behind-baby-bouncers-how-they-benefit-your-babys-development?srsltid=AfmBOoo0hqABT16dqDOT-T1dr1t_Yidta_P7yGojofPdn0HJPEnmYDm7

Baby Bouncers: Boosting Your Baby's Development Baby bouncers improve muscle development, motor skills, sensory development, and cognitive skills, including attention, memory, and problem- ...

3. ergobaby.com ergobaby.com/blog/post/bouncer-developmental-milestones?srsltid=AfmBOoodqoGjGO5Oa48bWIDl4il9fCze6UiEIBbasHa8BcEdflByeHxQ

How a Baby Bouncer Helps Meet Developmental Milestones Baby bouncers aid visual stimulation, leg strength, balance, coordination, cause and effect, spatial awareness, and parent-child interaction.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10323968/

Impact of Early Exposure to Play Materials on Motor ... The study concluded that a six-week treatment of early exposure to age-appropriate toys enhances motor development in high-risk neonates.

5. federalregister.gov federalregister.gov/documents/2015/10/19/2015-26386/safety-standard-for-infant-bouncer-seats

Safety Standard for Infant Bouncer Seats Based on that analysis, 11 percent of the injuries were severe, such as skull fractures and intracranial hemorrhages; and 41 percent were ...

6. federalregister.gov federalregister.gov/documents/2023/10/26/2023-23322/safety-standard-for-infant-and-infanttoddler-rockers

Safety Standard for Infant and Infant/Toddler Rockers The force of 45 lb. is approximately 25 percent greater than the 36 lb. weight of a 2.5-year-old male child in the 95th percentile. These ...

7. publications.aap.org publications.aap.org/aapnews/news/11688/Large-study-sheds-light-on-infant-deaths-in

Large study sheds light on infant deaths in sitting devices A 10-year study of 11,779 infant sleep-related deaths showed that 348 (3%) babies died in sitting devices, in most cases while in car seats.

8. researchgate.net researchgate.net/publication/9014327_Baby-bouncer-related_injuries_An_under-appreciated_risk

Baby-bouncer-related injuries: An under-appreciated risk One case report shows evidence of an infant having fatal extradural haemorrhages secondary to injury from a baby bouncer.

9. cpsc.gov cpsc.gov/s3fs-public/Letter-ASTM-F15-12-Subcommittee-April-2025_0.pdf?VersionId=dZckEJatv.oJb0TVdM.GFaXGljlohw4i

Letter-ASTM-F15-12-Subcommittee-April-2025_0.pdf To reduce the risk of infant suffocation or positional asphyxiation in seated infant products such as hand-held carriers, bouncers, swings, ...