- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60611
- Ann and Robert H. Lurie Children's Hospital of Chicago
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
Other Names:
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).
Other Names:
|
No Intervention: Parent education
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Test of Infant Motor Performance (TIMP) for motor outcome
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.
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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).
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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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PT Pal Application: Adherence
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.
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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.
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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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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Kathy Martin, DHSc, University of Indianapolis
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-2239
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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