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

NCT03759119 | Completed

• 1 other identifier: 2018-2239
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Test of Infant Motor Performance (TIMP) for motor outcome

  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 Outcomes (1)

• PT Pal Application: Adherence

  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.

Study Arms (2)

Tummy Time and Parent Education

EXPERIMENTAL

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.

Behavioral: Tummy time and parent education; Behavioral: Parent education only

Parent education

NO INTERVENTION

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.

Interventions

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.

Also known as: Group 1

Tummy Time and Parent Education

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.

Also known as: Group 2

Tummy Time and Parent Education

Eligibility Criteria

• Age: 35 Weeks - 44 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Indianapolis: lead
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator

Study Sites (1)

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

Chicago, Illinois, 60611, United States

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

• Kathy Martin, DHSc

  University of Indianapolis

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Outcome assessor investigator will be masked to all medical diagnoses of the infant
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dawn Drumm, PT Physical Therapist

Model Details: 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

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 29, 2018
• Study Start: February 6, 2019
• Primary Completion: March 23, 2020
• Study Completion: March 23, 2020
• Last Updated: March 24, 2020

Record last verified: 2020-03

Locations

US (1)