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Clinical Trials/NCT05878275
NCT05878275
Recruiting
Not Applicable

Supporting Infant Development: The Impact of a Tummy Time Intervention on Infant Development

University of Tennessee1 site in 1 country50 target enrollmentNovember 17, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prone Position
Sponsor
University of Tennessee
Enrollment
50
Locations
1
Primary Endpoint
Change in motor scale score on the Bailey Scales of Infant & Toddler Development
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The goal of this clinical trial is to examine the impact of an educational intervention on infant motor skill development. The main question it aims to answer is: Question 1) Does exposure to an educational intervention on infant development positively impact infant motor skill development? Researchers will compare the intervention group to the treatment as usual group see if there are differences in infant motor skill development.

The purpose of the proposed study is to determine if tummy time, play positions, screen time, and use of baby gear impacts early motor skill development in children. This is a Pilot study. A Pilot study is a small study that is carried out to collect information that will help in the planning of a larger study with the same topic.

Detailed Description

The purpose of the proposed study is to examine the impact of an educational intervention on infant motor skill development. A variety of factors influence infant development, including the home environment, maternal education, child rearing practices, caregiver handling, sleep position, baby gear use, and positioning during play. In recent years there have been changes in how babies are positioned when awake. For example, after the American Academy of Pediatrics (AAP) supine sleep recommendation in 1992, some parents reported not placing their infants on the stomach for play (tummy time) while awake due to a fear of sudden infant death syndrome (SIDS). Research suggests that babies who are not exposed to enough tummy time are at risk for delays in the development of their motor skills. Devices for infant positioning such as swings, bouncy seats, and carriers have also grown in popularity in recent years. More time in containers limits infant mobility and opportunities for exploration and less time in other positions for play. Many parents are not aware that varying how they handle and position their babies can positively influence development, while others have misconceptions about positioning and baby gear use. Additional research is needed that examines the impact of avoiding screen time, limiting the use of baby gear, regularly implementing tummy time, and varying an infant's position during play. It is also important that parents are aware of the need to initiate tummy time in the first days of life to increase infant tolerance of the position. The following items will constitute as 'baby gear' and will be utilized to determine if their use impacts early motor skill development in children: infant carrier, swing, bouncy seat, or a stationary activity center. The purpose of the proposed study is to determine if an educational intervention on tummy time, play positions, screen time, and use of baby gear impacts early motor skill development in children.

Registry
clinicaltrials.gov
Start Date
November 17, 2023
End Date
December 31, 2028
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Parent of the infant speaks and reads English
  • Individual is the parent or legal guardian of the infant.
  • Infant is 1 month of age or younger
  • Infant was carried to at least 37-weeks' gestation
  • Parent must own a cell phone will internet access and Zoom or Face Time capability
  • Parent must have a working email address.
  • Parent is over the age of 18 years
  • Family resides within a 30-min driving distance from the University of Tennessee Health Science Center,
  • Infant birthweight of at least 2500 g/ 5.5 pounds
  • Parental report of no know medical condition, health complication or problem since birth

Exclusion Criteria

  • Infant is regularly cared for by an adult other than their parent for 20 hours or more per week.

Outcomes

Primary Outcomes

Change in motor scale score on the Bailey Scales of Infant & Toddler Development

Time Frame: 6 months to 48 months of age

Scores range from 40 to 160, with higher scores indicating more advanced development

Secondary Outcomes

  • Change in fine motor scale score on the Ages & Stages Questionnaire-3(6 months to 48 months of age)

Study Sites (1)

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