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Enhanced Baby Items for Infant Development
N/A
Waitlist Available
Led By Elizabeth Simpson, Ph.D.
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Infants must be born full term (at least 37 weeks gestation)
Mother must speak English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 months
Awards & highlights
Study Summary
This trial will test whether baby items can help with infant development.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves common baby items rather than medical treatments, there aren't typical side effects. However, it's important to monitor the baby's comfort and any signs of distress while using these items.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My baby was born at or after 37 weeks of pregnancy.
Select...
I speak English.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cognitive skill as assessed via eye tracking
Infant Reactivity (Crying) assessed by the Face to Face/Still Face Procedure
Infant Reactivity (Smiling) assessed by the Face to Face/Still Face Procedure
+5 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Baby Carrier Group with Infant T-Shirt with LENAExperimental Treatment2 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 GroupExperimental Treatment1 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 LENAExperimental Treatment2 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 GroupExperimental Treatment1 Intervention
Participants in the group will be receiving a baby bouncer for use from infant's birth up to 8 months after birth.
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
898 Previous Clinical Trials
409,551 Total Patients Enrolled
Elizabeth Simpson, Ph.D.Principal Investigator - University of Miami
University of Miami
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.I speak English.
Research Study Groups:
This trial has the following groups:- Group 1: Baby Bouncer Group
- Group 2: Baby Carrier Group with Infant T-Shirt with LENA
- Group 3: Baby Carrier Group
- Group 4: Baby Bouncer Group with Infant T-Shirt with LENA
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is this medical experiment accommodating participants?
"Affirmative. Information available on clinicaltrials.gov highlights that this research trial, which was initially posted on February 7th 2020, is currently enrolling participants. Approximately 100 patients are needed from a single medical centre."
Answered by AI
Are there any vacancies left in this experiment for participants?
"Indeed, the information on clinicaltrials.gov verifies that this investigation is in progress and recruiting patients. This clinical trial was posted to the website on February 7th 2020 and last refreshed on April 25th 2022; it aims to enlist 100 individuals at one location."
Answered by AI
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