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Determining Optimal Dosage of Prone Positioning in Early Infancy

Determining Optimal Dosage of Prone Positioning to Facilitate Motor Development and Body Composition in Early Infancy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03134859
Acronym
Tummytime
Enrollment
35
Registered
2017-05-01
Start date
2017-05-31
Completion date
2020-12-31
Last updated
2017-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant Motor Development

Keywords

motor development

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.

Interventions

BEHAVIORALTummy Time

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

Sponsors

State University of New York - Upstate Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 8 Weeks
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Motor Development over time (longitudinal design)study entry to 18 months of ageMotor skills as determined by the Bayley Motor Scales, 3rd edition
Ponderal Index over time (longitudinal design)study entry to 18 months of ageEstimate of body composition in infants (weight in kg/height in meters cubed)

Contacts

Primary ContactErin E Wentz, PT, PhD, PCS
wentze@upstate.edu315.464.6577

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026