Child Development Clinical Trial
Official title:
Supporting Infant Development: The Impact of a Tummy Time Intervention on Infant Development
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Tennessee Health Science Center | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
University of Tennessee |
United States,
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
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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
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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
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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
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 |
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