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

March 23, 2020 updated by: Kathryn Martin, University of Indianapolis

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann and Robert H. Lurie Children's Hospital of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months to 10 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • 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.
Other Names:
  • Group 2
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.

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.
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
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Kathy Martin, DHSc, University of Indianapolis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2019

Primary Completion (Actual)

March 23, 2020

Study Completion (Actual)

March 23, 2020

Study Registration Dates

First Submitted

November 20, 2018

First Submitted That Met QC Criteria

November 28, 2018

First Posted (Actual)

November 29, 2018

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2018-2239

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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