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Completed

NCT Number: NCT03759119

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

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.

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Key information

Conditions

Premature Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

35 week–44 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ann and Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tummy time and parent education

Behavioral

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

Parent education only

Behavioral

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Indianapolis

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 29, 2018
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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