Feasibility Study of SPEEDI
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
10 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal