NCT01889108|CompletedPhase 1
Feasibility Study of SPEEDI
SPEEDI
Feasibility Study of Supporting Play, Exploration, & Early Development Intervention (SPEEDI) for Infants Born Preterm
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SPEEDI
Feasibility Study of Supporting Play, Exploration, & Early Development Intervention (SPEEDI) for Infants Born Preterm
Sponsor study identifier
interventional
10
1 country
1
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2013
Actual (reported)Study Completion
June 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
May 2013
Actual (reported)June 2013
Actual (reported)June 13, 2013
Actual (reported)June 28, 2013
Actual (reported)Test of Infant Motor Performance
Assessment of motor development
Change from baseline to the end of intervention at 3 months of adjusted age
Problem Solving Behaviors
Early infant problem solving
end of intervention at 3 months of adjusted age
Reaching
Reaching and object interaction measures
end of intervention at 3 months of adjusted age
Parent Child Interactions
End of intervention at 3 months of adjusted age
Usual care
Intervention with SPEEDI
Behavior intervention combining parent education and physical therapy intervention for preterm infants
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
10 participants (actual enrollment reported by the registry).
First Submitted
June 13, 2013
First Posted
June 28, 2013
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
Integrative Early Breastfeeding Support in NICU
Pain and Comfort During Endotracheal Suction in Premature Neonates
Contact the study team to confirm eligibility.
Primary Completion
May 2013
Actual (reported)Study Completion
June 2013
Actual (reported)Last Updated
August 22, 2023
Record last verified: 2023-08
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Source: ClinicalTrials.gov.
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