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

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03759119
• Other study ID #: 2018-2239
• Status: Completed
• Phase: N/A
• Start date: February 6, 2019
• Est. completion date: March 23, 2020

Study information

• Verified date: March 2020
• Source: University of Indianapolis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 23, 2020
• Est. primary completion date: March 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Weeks to 44 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Ann and Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Indianapolis	Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View Citation

Oberg GK, Campbell SK, Girolami GL, Ustad T, Jørgensen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PT Pal Application: Adherence	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.	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.