<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03759119</url>
  </required_header>
  <id_info>
    <org_study_id>2018-2239</org_study_id>
    <nct_id>NCT03759119</nct_id>
  </id_info>
  <brief_title>Use of a Tummy Time Intervention and Parent Education in Infants Born Preterm</brief_title>
  <official_title>Use of a Tummy Time Intervention and Parent Education in Infants Born Preterm: a Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Indianapolis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ann &amp; Robert H Lurie Children's Hospital of Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Indianapolis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to see if tummy time and parent education helps motor&#xD;
      development among infants born preterm. Participants will be recruited from Ann and Robert H.&#xD;
      Lurie Children's Hospital of Chicago neonatal intensive care unit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this randomized control trial will be to investigate the effects of a tummy&#xD;
      time intervention, as compared to standard care, on motor outcomes among premature infants&#xD;
      over a four-week period. Additionally, the study will measure tummy time adherence rates&#xD;
      between groups post intervention for an additional four weeks.&#xD;
&#xD;
      To meet this purpose, the following objectives will be addressed:&#xD;
&#xD;
        1. To determine if there will be a difference in motor outcome scores on the Test of Infant&#xD;
           Motor Performance (TIMP) among infants born preterm and utilizing a tummy time&#xD;
           intervention and parent education compared to those in the standard care group receiving&#xD;
           parent education only.&#xD;
&#xD;
        2. To determine if there will be a difference in adherence rates (average minutes/day)&#xD;
           between groups among infants born preterm utilizing a tummy time intervention and parent&#xD;
           education compared to those in the standard care group receiving parent education only.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2019</start_date>
  <completion_date type="Actual">March 23, 2020</completion_date>
  <primary_completion_date type="Actual">March 23, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This will be a randomized controlled trial using a pretest /posttest control group design to allow for comparison between an intervention group that receives tummy time and parent education and a standard of care group that receives parent education only</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>Outcome assessor investigator will be masked to all medical diagnoses of the infant</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Test of Infant Motor Performance (TIMP) for motor outcome</measure>
    <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.</time_frame>
    <description>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 &amp; Westcott, 2005).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PT Pal Application: Adherence</measure>
    <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.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Premature Birth</condition>
  <arm_group>
    <arm_group_label>Tummy Time and Parent Education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parent education</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tummy time and parent education</intervention_name>
    <description>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.</description>
    <arm_group_label>Tummy Time and Parent Education</arm_group_label>
    <other_name>Group 1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parent education only</intervention_name>
    <description>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.&#xD;
Steps of the intervention for group 2 (standard care).&#xD;
Complete educational session with primary investigator.&#xD;
Adherence during the four-week intervention period will be measured remotely through the PT Pal® application.</description>
    <arm_group_label>Tummy Time and Parent Education</arm_group_label>
    <other_name>Group 2</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        To be eligible to participate in the study, participants must meet the following inclusion&#xD;
        criteria:&#xD;
&#xD;
          -  born premature (&lt; 37 weeks' gestation),&#xD;
&#xD;
          -  require medical care within Lurie Children's NICU, be between 35 and 44 weeks&#xD;
             postmenstrual age.&#xD;
&#xD;
          -  Primary parent must have a working mobile device.&#xD;
&#xD;
          -  Participants must be English or Spanish speaking as primary language.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  primary parent does not having a working mobile device and&#xD;
&#xD;
          -  Speaking a language other than English or Spanish.&#xD;
&#xD;
          -  Unable to be placed in the prone position,&#xD;
&#xD;
          -  Physiologically unstable for handling&#xD;
&#xD;
          -  Orally intubated or have a tracheostomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Weeks</minimum_age>
    <maximum_age>44 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathy Martin, DHSc</last_name>
    <role>Study Chair</role>
    <affiliation>University of Indianapolis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ann and Robert H. Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>25621433</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>11598602</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>11552873</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22336194</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>March 23, 2020</last_update_submitted>
  <last_update_submitted_qc>March 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Indianapolis</investigator_affiliation>
    <investigator_full_name>Kathryn Martin</investigator_full_name>
    <investigator_title>Dawn Drumm, PT Physical Therapist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03759119
org study id: 2018-2239
nct id: NCT03759119
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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:

        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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This will be a randomized controlled trial using a pretest /posttest control group design to allow for comparison between an intervention group that receives tummy time and parent education and a standard of care group that receives parent education only
primary purpose: Treatment
masking: Single (Investigator)
masking description: Outcome assessor investigator will be masked to all medical diagnoses of the infant
measure: 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.
description: 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).
measure: 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.
description: 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.
arm group label: Tummy Time and Parent Education
arm group type: Experimental
description: 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.
arm group label: Parent education
arm group type: No Intervention
description: 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.
intervention type: Behavioral
intervention name: Tummy time and parent education
description: 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.
arm group label: Tummy Time and Parent Education
other name: Group 1
intervention type: Behavioral
intervention name: Parent education only
description: 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.
arm group label: Tummy Time and Parent Education
other name: Group 2
criteria: 
gender: All
minimum age: 35 Weeks
maximum age: 44 Weeks
healthy volunteers: No
last name: Kathy Martin, DHSc
role: Study Chair
affiliation: University of Indianapolis
facility: 
country: United States
citation: 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.
PMID: 25621433
citation: 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.
PMID: 11598602
citation: 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.
PMID: 11552873
citation: 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.
PMID: 22336194
responsible party type: Principal Investigator
investigator affiliation: University of Indianapolis
investigator full name: Kathryn Martin
investigator title: Dawn Drumm, PT Physical Therapist
mesh term: Premature Birth