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

University of Indianapolis

Status: Completed

Conditions: Premature Birth

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03759119

2018-2239

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 35 to 44 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

Tummy Time and Parent Education

Experimental group

Description:

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.

Treatment:

Behavioral: Tummy time and parent education

Behavioral: Parent education only

Parent education

No Intervention group

Description:

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.