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

NCT03759119 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2020-03-24

No results posted yet for this study

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.

Conditions

  • Premature Birth

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago

    collaborator OTHER
  • University of Indianapolis

    lead OTHER

Principal Investigators

  • Kathy Martin, DHSc · University of Indianapolis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Weeks
Max Age
44 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-06
Primary Completion
2020-03-23
Completion
2020-03-23

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03759119 on ClinicalTrials.gov