Supporting Infant Development

Overview

The goal of this clinical trial is to examine the impact of an educational intervention on infant development 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.

Full Title of Study: “Supporting Infant Development: The Impact of a Tummy Time Intervention on Infant Development”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Double (Investigator, Outcomes Assessor)
• Study Primary Completion Date: December 31, 2027

Detailed Description

The purpose of the proposed study is to examine the impact of an educational intervention on infant development 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 exersaucer. 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.

Interventions

• Other: Parent Informational Session
  • 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.

Arms, Groups and Cohorts

• No Intervention: Usual Care Group
  • Usual care group will receive a brochure on the importance of tummy time and limiting baby gear.
• Experimental: Treatment Group
  • parental education session that includes information and a video on avoiding screentime 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 intervention group can request a Zoom consultation with the Principal Investigator if they have questions or need guidance with implementing tummy time.

Clinical Trial Outcome Measures

Primary Measures

• 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 Measures

• 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

Participating in This Clinical Trial

Inclusion Criteria

1. Parent of the infant speaks and reads English 2. Individual is the parent or legal guardian of the infant. 3. Infant is 1 month of age or younger 4. Infant was carried to at least 37-weeks' gestation 5. Parent must own a cell phone will internet access and Zoom or FaceTime capability 6. Parent must have a working email address. 7. Parent is over the age of 18 years 8. Family resides within a 30-min driving distance from the University of Tennessee Health Science Center, 9. Infant birthweight of at least 2500 g/ 5.5 pounds 10. Parental report of no know medical condition, health complication or problem since birth 11. that could have an impact on infant movement behaviors or development. 12. Parent reports that infant does not have a diagnosis of Gastroesophageal reflux disease (GERD). 13. 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.

Gender Eligibility: All

Minimum Age: 1 Day

Maximum Age: 4 Weeks

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • University of Tennessee
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Anne H Zachry, PhD, Principal Investigator, University of Tennessee
• Overall Contact(s)
  • Anne H Zachry, PhD, 9014963950, azachry@uthsc.edu

Citations Reporting on Results

De Bock F, Braun V, Renz-Polster H. Deformational plagiocephaly in normal infants: a systematic review of causes and hypotheses. Arch Dis Child. 2017 Jun;102(6):535-542. doi: 10.1136/archdischild-2016-312018. Epub 2017 Jan 19.

Dudek-Shriber L, Zelazny S. The effects of prone positioning on the quality and acquisition of developmental milestones in four-month-old infants. Pediatr Phys Ther. 2007 Spring;19(1):48-55. doi: 10.1097/01.pep.0000234963.72945.b1.

Felzer-Kim IT, Erickson K, Adkins C, Hauck JL. Wakeful Prone "Tummy Time" During Infancy: How Can We Help Parents? Phys Occup Ther Pediatr. 2020;40(6):651-668. doi: 10.1080/01942638.2020.1742847. Epub 2020 Mar 19.

Hewitt L, Kerr E, Stanley RM, Okely AD. Tummy Time and Infant Health Outcomes: A Systematic Review. Pediatrics. 2020 Jun;145(6):e20192168. doi: 10.1542/peds.2019-2168. Epub 2020 May 5.

Mendres-Smith AE, Borrero JC, Castillo MI, Davis BJ, Becraft JL, Hussey-Gardner B. Tummy time without the tears: The impact of parent positioning and play. J Appl Behav Anal. 2020 Sep;53(4):2090-2107. doi: 10.1002/jaba.715. Epub 2020 May 20.

Wen LM, Baur LA, Simpson JM, Rissel C, Flood VM. Effectiveness of an early intervention on infant feeding practices and "tummy time": a randomized controlled trial. Arch Pediatr Adolesc Med. 2011 Aug;165(8):701-7. doi: 10.1001/archpediatrics.2011.115.

Zachry AH, Kitzmann KM. Caregiver awareness of prone play recommendations. Am J Occup Ther. 2011 Jan-Feb;65(1):101-5. doi: 10.5014/ajot.2011.09100.

Zachry AH, Nolan VG, Hand SB, Klemm SA. Infant Positioning, Baby Gear Use, and Cranial Asymmetry. Matern Child Health J. 2017 Dec;21(12):2229-2236. doi: 10.1007/s10995-017-2344-6.