PrematurePhase 1SPEEDINCT01889108
Feasibility Study of SPEEDI
A Phase 1 study testing SPEEDI in people with Premature, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The proposed feasibility study will evaluate the investigators ability to conduct a clinical trial of a novel intervention (SPEEDI) which addresses a striking gap in the literature. Read more about this study
- Who is it for?
- Ages Up to 34 weeks
- Conditions the study is for
- Premature
- What is being tested?
- SPEEDI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jun 2013
- Phase
- Phase 1
- 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 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infants born preterm at 34 weeks Post Menstrual Age (PMA) or less
- medically stable,
- off ventilator support,
- demonstrate thermoregulation in an open crib by 35 weeks of PMA,
- live within 60 minutes of the hospital, and
- have one parent who is English speaking and willing to participate in the study intervention and assessments
Who cannot join
- genetic syndrome or
- musculoskeletal deformity
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Feasibility Study of Supporting Play, Exploration, & Early Development Intervention (SPEEDI) for Infants Born Preterm
The proposed feasibility study will evaluate the investigators ability to conduct a clinical trial of a novel intervention (SPEEDI) which addresses a striking gap in the literature. Supporting Play, Exploration, and Early Development Intervention (SPEEDI) differs from current early intervention practices in 2 important ways. First it bridges the traditional gap in services from the Neonatal Intensive Care Unit (NICU) to home providing ongoing and intensive support for developmental activities when parents are establishing care giving routines. Second, in contrast to wide-ranging intervention provided by current early intervention models, SPEEDI uses an action perception model to target specific behaviors which lead to improved early motor abilities and provide a foundation for learning.[6] The purpose of this feasibility study is to extend the investigators preliminary data and evaluate the feasibility of conducting a randomized control trial to evaluate the efficacy of SPEEDI.
- Conditions
- Premature
- Being tested
- SPEEDI
- Keywords
- Premature, Development, Motor, Cognitive, Parent
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPEEDIBehavioural
Also called Developed for this study
Behavior intervention combining parent education and physical therapy intervention for preterm infants
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual care |
| Intervention group | Experimental | Intervention with SPEEDI Receives: Behavioral: SPEEDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test of Infant Motor Performance
Assessment of motor development
Measured: Change from baseline to the end of intervention at 3 months of adjusted age
Problem Solving Behaviors
Early infant problem solving
Measured: end of intervention at 3 months of adjusted age
Reaching
Reaching and object interaction measures
Measured: end of intervention at 3 months of adjusted age
Secondary outcomes (1)
Parent Child Interactions
Behavioral coding of parent child interactions
Measured: End of intervention at 3 months of adjusted age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startJul 2012
- Primary completionMay 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematureStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889108
- Sponsor's protocol ID
- VCU_HM13949
- Acronym
- SPEEDI
- Status last verified
- Aug 2023
- First submitted
- 13 Jun 2013
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Supporting Play, Exploration, & Early Development Intervention (SPEEDI) for Infants Born Preterm
- ClinicalTrials.gov ID
- NCT01889108
- Acronym / sponsor ID
- SPEEDI / VCU_HM13949
- Conditions
- Premature
- Keywords
- Premature, Development, Motor, Cognitive, Parent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 28 Jun 2013 (estimated)
- 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 feasibility study will evaluate the investigators ability to conduct a clinical trial of a novel intervention (SPEEDI) which addresses a striking gap in the literature. Supporting Play, Exploration, and Early Development Intervention (SPEEDI) differs from current early intervention practices in 2 important ways. First it bridges the traditional gap in services from the Neonatal Intensive Care Unit (NICU) to home providing ongoing and intensive support for developmental activities when parents are establishing care giving routines. Second, in contrast to wide-ranging intervention provided by current early intervention models, SPEEDI uses an action perception model to target specific behaviors which lead to improved early motor abilities and provide a foundation for learning.[6] The purpose of this feasibility study is to extend the investigators preliminary data and evaluate the feasibility of conducting a randomized control trial to evaluate the efficacy of SPEEDI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual care |
| Intervention group | Experimental | Behavioral: SPEEDIIntervention with SPEEDI |
Who may qualify
- Ages
- Up to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- infants born preterm at 34 weeks Post Menstrual Age (PMA) or less
- medically stable,
- off ventilator support,
- demonstrate thermoregulation in an open crib by 35 weeks of PMA,
- live within 60 minutes of the hospital, and
Key exclusion criteria (2 listed)
- genetic syndrome or
- musculoskeletal deformity
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 |
|---|---|---|
| SPEEDIAlso: Developed for this studyBehavior intervention combining parent education and physical therapy intervention for preterm infants | Behavioural | Intervention group |
Primary outcome
Test of Infant Motor Performance
Time frame: Change from baseline to the end of intervention at 3 months of adjusted age
Assessment of motor development
Problem Solving Behaviors
Time frame: end of intervention at 3 months of adjusted age
Early infant problem solving
Reaching
Time frame: end of intervention at 3 months of adjusted age
Reaching and object interaction measures
1 secondary outcome
Parent Child Interactions
Time frame: End of intervention at 3 months of adjusted age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SPEEDI in people with Premature, run by Virginia Commonwealth University at 1 site in United States.
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 6 inclusion and 2 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: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test of Infant Motor Performance (time frame: Change from baseline to the end of intervention at 3 months of adjusted age). The study lists 3 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 22 Aug 2023; AzTrials last refreshed its copy on 30 Oct 2026.