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

Child Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05878275
• Other study ID #: 23-09209-XP
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: February 2024
• Source: University of Tennessee
• Contact: Anne H Zachry, PhD
• Phone: 9014963950
• Email: azachry[@]uthsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 4 Weeks

Eligibility

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 Face Time 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.

Related Conditions & MeSH terms

• Child Development
• Prone Position

Intervention

Behavioral:
• Parent Informational Session
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.

Locations

Country	Name	City	State
United States	University of Tennessee Health Science Center	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in motor scale score on the Bailey Scales of Infant & Toddler Development	Scores range from 40 to 160, with higher scores indicating more advanced development	6 months to 48 months of age
Secondary	Change in fine motor scale score on the Ages & Stages Questionnaire-3	Scores range from 0 to 60 with higher scores indicating more advanced motor development	6 months to 48 months of age