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NCT05878275 | Recruiting | Prone Position


Supporting Infant Development Through Tummy Time, Positioning, and Limiting Baby Gear
Sponsor:

University of Tennessee

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.

Condition or disease

Prone Position

Child Development

Intervention/treatment

Parent Informational Session

Phase

Not Applicable

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.}}

Study Type : Interventional
Estimated Enrollment : 50 participants
Masking : Double
Masking Description : Single Blind
Primary Purpose : Treatment
Official Title : Supporting Infant Development: The Impact of a Tummy Time Intervention on Infant Development
Actual Study Start Date : November 17, 2023
Estimated Primary Completion Date : December 31, 2027
Estimated Study Completion Date : December 31, 2028
Arm Intervention/treatment

No Intervention: Usual Care Group Receiving an Informational Tummy Time Brochure

Usual care group will receive a brochure on the importance of tummy time and limiting baby gear.

Experimental: Parent Informational Session

Parental education session that includes information and a video on avoiding screen time in the first two years of life, the importance and benefits of infants being exposed to tummy time, varying play positions and limiting time in baby gear. Additional information will be provided on the importance of implementing tummy time during the first month of life as well as different ways to implement tummy time and how to increase infant tolerance to tummy time. Parents in the Parent Informational Session can request a Zoom consultation with the Principal Investigator if the parents have questions or need guidance with implementing tummy time.

Ages Eligible for Study: 1 Day to 4 Weeks
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
  • that could have an impact on infant movement behaviors or development.
  • Parent reports that infant does not have a diagnosis of Gastroesophageal reflux disease (GERD).
  • Family does not expect to move from the area within 3 years of enrollment
Exclusion Criteria
  • 1. Infant is regularly cared for by an adult other than their parent for 20 hours or more per week.

Supporting Infant Development Through Tummy Time, Positioning, and Limiting Baby Gear

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Supporting Infant Development Through Tummy Time, Positioning, and Limiting Baby Gear

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Locations


Recruiting

United States, Tennessee

University of Tennessee Health Science Center

Memphis, Tennessee, United States, 38163

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