NCT03759119

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: University of Indianapolis · Academic / Other
• Sex: All
• Age: 35 Weeks – 44 Weeks
• Healthy volunteers: Not accepted

Summary

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

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: 1. 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. 2. 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.

Conditions

• Premature Birth

Interventions

Type	Name	Description
BEHAVIORAL	Tummy time and parent education	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.
BEHAVIORAL	Parent education only	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.

Timeline

• Start date: 2019-02-06
• Primary completion: 2020-03-23
• Completion: 2020-03-23
• First posted: 2018-11-29
• Last updated: 2020-03-24

Locations

1 site across 1 country: United States