Clinical trial NCT05878275: Supporting Infant Development Through Tummy Time, Positioning, and Limiting Baby Gear
Official title: Supporting Infant Development: The Impact of a Tummy Time Intervention on Infant Development
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prone Position
Child Development
Keywords: Prone Position
Tummy Time
Infant Development
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Longitudinal experimental design
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in motor scale score on the Bailey Scales of Infant & Toddler Development
timeFrame: 6 months to 48 months of age
Secondary outcomes:
measure: Change in fine motor scale score on the Ages & Stages Questionnaire-3
timeFrame: 6 months to 48 months of age
Other outcomes:
Locations:
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Anne H Zachry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.
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.
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.
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.