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| Name | Class |
|---|---|
| Ann & Robert H Lurie Children's Hospital of Chicago | OTHER |
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The purpose of this research study is to see if tummy time and parent education helps motor development among infants born preterm. Participants will be recruited from Ann and Robert H. Lurie Children's Hospital of Chicago neonatal intensive care unit.
The purpose of this randomized control trial will be to investigate the effects of a tummy time intervention, as compared to standard care, on motor outcomes among premature infants over a four-week period. Additionally, the study will measure tummy time adherence rates between groups post intervention for an additional four weeks.
To meet this purpose, the following objectives will be addressed:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tummy Time and Parent Education | Experimental | This group will receive tummy time and parent education and be encouraged to perform tummy time on their own. They will utilize the PT Pal application to record their tummy time adherence. The primary investigator performs the intervention to the participants two times a day for 10 minutes for 4 weeks. |
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| Parent education | No Intervention | This group will receive parent education only and utilize the PT Pal application to record their adherence. The primary caregiver will be encouraged to perform the same dosage of tummy time (2x/day, 10 minutes each, 4 weeks) and record their adherence on the PT Pal application. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tummy time and parent education | Behavioral | Participants will receive tummy time positioning while awake for 10 minutes two times a day. Physiological monitoring will be maintained throughout the entire intervention and the intervention will be adjusted if needed to maintain stability. Participants will also receive parent education on tummy time prior to the tummy time intervention. The primary investigator will perform the tummy time intervention. Participants will be encouraged to continue performing tummy time on their own and record their adherence via the PT Pal application. |
| Measure | Description | Time Frame |
|---|---|---|
| Test of Infant Motor Performance (TIMP) for motor outcome | The TIMP is a functional motor scale for newborns, including those born premature, up to infants four months corrected age, and was specifically designed for use in neonatal intensive care units (Rose & Westcott, 2005). | Change in motor outcome will be measured at initiation and at 8 weeks. Each participant will be enrolled in the study for 8 weeks. The study is expected to be completed within 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| PT Pal Application: Adherence | The PT Pal application will be utilized to generate information back to the PI on adherence with tummy time outcomes of the prescription recommendations and thus serves as an adherence component for both the intervention and the standard care group. | Change in adherence will be measured at initiation and at 8 weeks. Each participant will be enrolled in the study for 8 weeks. The study is expected to be completed within 6 months. |
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Inclusion Criteria:
To be eligible to participate in the study, participants must meet the following inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathy Martin, DHSc | University of Indianapolis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann and Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25621433 | Background | Bentzley JP, Coker-Bolt P, Moreau NG, Hope K, Ramakrishnan V, Brown T, Mulvihill D, Jenkins D. Kinematic measurement of 12-week head control correlates with 12-month neurodevelopment in preterm infants. Early Hum Dev. 2015 Feb;91(2):159-64. doi: 10.1016/j.earlhumdev.2015.01.001. Epub 2015 Jan 23. | |
| 11598602 | Background |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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This will be a randomized controlled trial using a pretest /posttest control group design to allow for comparison between an intervention group that receives tummy time and parent education and a standard of care group that receives parent education only
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Outcome assessor investigator will be masked to all medical diagnoses of the infant
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| Parent education only | Behavioral | Participants will receive the same tummy time education as those in the intervention group and will be asked to continue the intervention on their own and record their adherence via the PT Pal application. Steps of the intervention for group 2 (standard care).
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| Campbell SK, Hedeker D. Validity of the Test of Infant Motor Performance for discriminating among infants with varying risk for poor motor outcome. J Pediatr. 2001 Oct;139(4):546-51. doi: 10.1067/mpd.2001.117581. |
| 11552873 | Background | Lekskulchai R, Cole J. Effect of a developmental program on motor performance in infants born preterm. Aust J Physiother. 2001;47(3):169-76. doi: 10.1016/s0004-9514(14)60264-6. |
| 22336194 | Background | Oberg GK, Campbell SK, Girolami GL, Ustad T, Jorgensen L, Kaaresen PI. Study protocol: an early intervention program to improve motor outcome in preterm infants: a randomized controlled trial and a qualitative study of physiotherapy performance and parental experiences. BMC Pediatr. 2012 Feb 15;12:15. doi: 10.1186/1471-2431-12-15. |
| D000091642 | Urogenital Diseases |