CompletedPhase 1

Feasibility Study of SPEEDI

United States10 participantsStarted 2012-07

Plain-language 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. 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.

Who can participate

Age range

34 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * genetic syndrome or * musculoskeletal deformity

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Test of Infant Motor Performance

Timeframe: Change from baseline to the end of intervention at 3 months of adjusted age

Problem Solving Behaviors

Timeframe: end of intervention at 3 months of adjusted age

Reaching

Timeframe: end of intervention at 3 months of adjusted age

Trial details

NCT IDNCT01889108

SponsorVirginia Commonwealth University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-05

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