Use of a Tummy Time Intervention and Parent Education in Infants Born Preterm
NCT ID: NCT03759119
Last Updated: 2020-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
26 participants
INTERVENTIONAL
2019-02-06
2020-03-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Determining Optimal Dosage of Prone Positioning in Early Infancy
NCT03134859
Parent Training for Parents of Toddlers Born Very Premature:
NCT05217615
Development Training in Babies Born Preterm
NCT00268931
Supporting Infant Development Through Tummy Time, Positioning, and Limiting Baby Gear
NCT05878275
Assisted Exercise in Prematurity; Effects and Mechanisms
NCT00580099
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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.
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.
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
35 Weeks
44 Weeks
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ann & Robert H Lurie Children's Hospital of Chicago
OTHER
University of Indianapolis
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kathryn Martin
Dawn Drumm, PT Physical Therapist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kathy Martin, DHSc
Role: STUDY_CHAIR
University of Indianapolis
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018-2239
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.