Determining Optimal Dosage of Prone Positioning in Early Infancy (Tummytime)

May 2, 2017 updated by: Erin Wentz PT PhD PCS, State University of New York - Upstate Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 month (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Behavioral: Tummy Time
deliberate, supervised play time with the baby on his or her front (tummy) when he or she is awake
Other Names:
  • prone positioning
Experimental: 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
Behavioral: Tummy Time
deliberate, supervised play time with the baby on his or her front (tummy) when he or she is awake
Other Names:
  • prone positioning
Experimental: >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
Behavioral: Tummy Time
deliberate, supervised play time with the baby on his or her front (tummy) when he or she is awake
Other Names:
  • prone positioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor Development over time (longitudinal design)
Time Frame: study entry to 18 months of age
Motor skills as determined by the Bayley Motor Scales, 3rd edition
study entry to 18 months of age
Ponderal Index over time (longitudinal design)
Time Frame: study entry to 18 months of age
Estimate of body composition in infants (weight in kg/height in meters cubed)
study entry to 18 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York - Upstate Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2017

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

April 21, 2017

First Submitted That Met QC Criteria

April 26, 2017

First Posted (Actual)

May 1, 2017

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TTDSUNYMU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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