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

Not Applicable

Completed

• Conditions: Premature Birth
• Interventions: Behavioral: Tummy time and parent education; Behavioral: Parent education only

• Registration Number: NCT03759119
• Lead Sponsor: University of Indianapolis

Brief 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.

Study Timeline

• Study First Submitted: 2018-11-20
• Study First Submitted QC: 2018-11-28
• Study First Posted: 2018-11-29
• Study Start: 2019-02-06
• Status Verified: 2020-03
• Primary Completion: 2020-03-23
• Study Completion: 2020-03-23
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tummy Time and Parent Education	Tummy time and parent education	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.
Tummy Time and Parent Education	Parent education only	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.

Primary Outcome Measures

Name	Time	Method
Test of Infant Motor Performance (TIMP) for motor outcome	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.	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).

Secondary Outcome Measures

Name	Time	Method
PT Pal Application: Adherence	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.	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.

Trial Locations

Locations (1)

Ann and Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States