An interventional study of Tummy time and parent education and Parent education only in Premature Birth, sponsored by University of Indianapolis. Completed at 1 site in United States. Open to participants aged 35 Weeks to 44 Weeks. Per ClinicalTrials.gov, last updated 2020-03-24.
Sponsored by University of Indianapolis · Not applicable, Interventional, and Treatment
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:
To be eligible to participate in the study, participants must meet the following inclusion criteria:
Exclusion criteria:
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 · Behavioral: Parent education only
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.
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.
Also known as: Group 1
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.
Also known as: Group 2
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).
Time frame: 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.
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.
Time frame: 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.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University of Indianapolis