Infant Motor DevelopmentTummytimeNCT03134859
Determining Optimal Dosage of Prone Positioning in Early Infancy
A study testing Tummy Time in people with Infant Motor Development, run by State University of New York - Upstate Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Infant Motor Development
- What is being tested?
- Tummy Time
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- May 2017to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 8 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- full term infants with typical development
Who cannot join
- premature birth before 37 weeks gestation; known medical condition or diagnosis; any complications that limit full participation in the intervention activities
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- Tummy Time
- Keywords
- motor development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tummy TimeBehavioural
Also called prone positioning
deliberate, supervised play time with the baby on his or her front (tummy) when he or she is awake
| Study group | Role | What they receive |
|---|---|---|
| 0 to 30 min/day tummy time | Experimental | 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 Receives: Behavioral: Tummy Time |
| 31-60 min/day tummy time | Experimental | 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 Receives: Behavioral: Tummy Time |
| >61 min/day tummy time | Experimental | 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 Receives: Behavioral: Tummy Time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Development over time (longitudinal design)
Motor skills as determined by the Bayley Motor Scales, 3rd edition
Measured: study entry to 18 months of age
Ponderal Index over time (longitudinal design)
Estimate of body composition in infants (weight in kg/height in meters cubed)
Measured: study entry to 18 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study startMay 2017 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Motor DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin Wentz PT PhD PCS, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134859
- Sponsor's protocol ID
- TTDSUNYMU
- Acronym
- Tummytime
- Status last verified
- May 2017
- First submitted
- 21 Apr 2017
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Optimal Dosage of Prone Positioning to Facilitate Motor Development and Body Composition in Early Infancy
- ClinicalTrials.gov ID
- NCT03134859
- Acronym / sponsor ID
- Tummytime / TTDSUNYMU
- Conditions
- Infant Motor Development
- Keywords
- motor development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- May 2017 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 1 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0 to 30 min/day tummy time | Experimental | Behavioral: Tummy TimeGroup 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 |
| 31-60 min/day tummy time | Experimental | Behavioral: Tummy TimeGroup 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 |
| >61 min/day tummy time | Experimental | Behavioral: Tummy TimeGroup 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 |
Who may qualify
- Ages
- Up to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- full term infants with typical development
Key exclusion criteria (1 listed)
- premature birth before 37 weeks gestation; known medical condition or diagnosis; any complications that limit full participation in the intervention activities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tummy TimeAlso: prone positioningdeliberate, supervised play time with the baby on his or her front (tummy) when he or she is awake | Behavioural | 0 to 30 min/day tummy time, 31-60 min/day tummy time, >61 min/day tummy time |
Primary outcome
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
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Tummy Time in people with Infant Motor Development, run by State University of New York - Upstate Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erin E Wentz, PT, PhD, PCS (315.464.6577, wentze@upstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Development over time (longitudinal design) (time frame: study entry to 18 months of age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.