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NCT Number: NCT05878275

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

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.

Recruiting

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Key information

Age range

1 day–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Parent Informational Session

Behavioral

Parents will receive a brochure on the importance of tummy time and limiting baby gear and watch a video on the importance of tummy time and limiting baby gear and receive support for implementing tummy time if requested.

Primary outcomes

  1. 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

  1. Change in fine motor scale score on the Ages & Stages Questionnaire-3

    Time frame: 6 months to 48 months of age

    Scores range from 0 to 60 with higher scores indicating more advanced motor development

Study contacts

Contact information is provided by the study sponsor or research team.

Anne H Zachry, PhD

CONTACT

[email protected]

9014963950

Lauren Woods, PhD

CONTACT

[email protected]

901-268-0105

Sponsors and collaborators

Lead sponsor

University of Tennessee

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
May 26, 2023
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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