Use of a Tummy Time Intervention and Parent Education in Infants Born Preterm

Study Overview
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Brief Summary
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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.

Detailed Description
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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: To determine if there will be a difference in motor outcome scores on the Test of Infant Motor Performance (TIMP) among infants born preterm and utilizing a tummy time intervention and parent education compared to those in the standard care group receiving parent education only. To determine if there will be a difference in adherence rates (average minutes/day) between groups among infants born preterm utilizing a tummy time intervention and parent education compared to those in the standard care group receiving parent education only.

Official Title
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Use of a Tummy Time Intervention and Parent Education in Infants Born Preterm: a Randomized Control Trial

Conditions
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Premature Birth

Intervention / Treatment
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* Behavioral: Tummy time and parent education
* Behavioral: Parent education only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be eligible to participate in the study, participants must meet the following inclusion criteria: born premature (< 37 weeks' gestation), require medical care within Lurie Children's NICU, be between 35 and 44 weeks postmenstrual age. Primary parent must have a working mobile device. Participants must be English or Spanish speaking as primary language. Exclusion criteria: primary parent does not having a working mobile device and Speaking a language other than English or Spanish. Unable to be placed in the prone position, Physiologically unstable for handling Orally intubated or have a tracheostomy

Ages Eligible for Study
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Minimum Age: 35 Weeks
Maximum Age: 44 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tummy Time and Parent Education<br>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. | Behavioral: Tummy time and parent education<br>* 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.<br>* Other names: Group 1;Behavioral: Parent education only<br>* 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). Complete educational session with primary investigator. Adherence during the four-week intervention period will be measured remotely through the PT Pal® application.<br>* Other names: Group 2;|
| No Intervention: Parent education<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. |