Determining Optimal Dosage of Prone Positioning in Early Infancy

NCT ID: NCT03134859

Last Updated: 2017-05-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-31
• Study Completion Date: 2020-12-31

Brief Summary

The proposed study is a longitudinal, randomized control trial designed to determine the dosage of daily 'tummy time' needed in early infancy to influence ideal motor development and healthy body composition. Infants will be randomly assigned to one of three 'tummy time' groups: a group prescribed 0 to 30 minutes per day; a group prescribed 31 to 60 minutes per day; and, a group prescribed 61 or more minutes per day. Families will be encouraged to achieve the maximal minutes prescribed for their group and will keep a log of their daily tummy time. Participating infants will be assessed in their home for motor development and body composition at study entry and again every month for 12 months, at 15 months of age and at 18 months of age.

Detailed Description

Prone positioning or 'tummy time' in early infancy is advocated as important to support early motor development, improve overall strength, and prevent flattening of the back of the head. The American Academy of Pediatrics state that "a certain amount of prone positioning, or 'tummy time,' while the infant is awake and being observed is recommended to help prevent the development of flattening of the occiput and to facilitate development of the upper shoulder girdle necessary for timely attainment of certain motor milestones." However, specific recommendations on appropriate dosage of prone positioning are not available. In the absence of these specific recommendations, many infants may not be engaging in sufficient 'tummy time' for timely motor development. Moreover, insufficient 'tummy time' is linked to heightened obesity risk in early life. Given the increasing incidence of obesity in infants, primary preventative efforts need to begin early to reduce this risk.

The proposed study is a longitudinal, randomized control trial designed to determine the dosage of daily 'tummy time' needed in early infancy to influence ideal motor development and healthy body composition. Infants will be randomly assigned to one of three 'tummy time' groups: a group prescribed 0 to 30 minutes per day; a group prescribed 31 to 60 minutes per day; and, a group prescribed 61 or more minutes per day. Families will be encouraged to achieve the maximal minutes prescribed for their group and will keep a log of their daily tummy time. Participating infants will be assessed in their home for motor development and body composition at study entry and again every month for 12 months, at 15 months of age and at 18 months of age. Once a participant can independently transition in and out of the sitting position, the family will no longer be responsible for performing deliberate 'tummy time' activities or logging, but monthly motor development and body composition will continue to be monitored until the participant is 18 months of age.

Conditions

Infant Motor Development

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

0 to 30 min/day tummy time

Group tasked to engage in an accumulation of 0 to 30 minutes of deliberate tummy time activities daily from study entry until the time at which the infant can independently transition in and out of sitting

Group Type: EXPERIMENTAL

Tummy Time

Intervention Type: BEHAVIORAL

deliberate, supervised play time with the baby on his or her front (tummy) when he or she is awake

31-60 min/day tummy time

Group tasked to engage in an accumulation of 31 to 60 minutes of deliberate tummy time activities daily from study entry until the time at which the infant can independently transition in and out of sitting

Group Type: EXPERIMENTAL

Tummy Time

Intervention Type: BEHAVIORAL

deliberate, supervised play time with the baby on his or her front (tummy) when he or she is awake

>61 min/day tummy time

Group tasked to engage in an accumulation of 61 or more minutes of deliberate tummy time activities daily from study entry until the time at which the infant can independently transition in and out of sitting

Group Type: EXPERIMENTAL

Tummy Time

Intervention Type: BEHAVIORAL

deliberate, supervised play time with the baby on his or her front (tummy) when he or she is awake

Interventions

Tummy Time

deliberate, supervised play time with the baby on his or her front (tummy) when he or she is awake

Intervention Type: BEHAVIORAL

Other Intervention Names

prone positioning

Eligibility Criteria

Inclusion Criteria

• full term infants with typical development

Exclusion Criteria

• premature birth before 37 weeks gestation; known medical condition or diagnosis; any complications that limit full participation in the intervention activities

• Maximum Eligible Age: 8 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

State University of New York - Upstate Medical University

OTHER

Sponsor Role: lead

Responsible Party

Erin Wentz PT PhD PCS

Assistant Professor, Department of Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Erin E Wentz, PT, PhD, PCS

Role: CONTACT

wentze@upstate.edu

315.464.6577

Other Identifiers

TTDSUNYMU

Identifier Type: -

Identifier Source: org_study_id