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Feasibility Study of SPEEDI (SPEEDI)

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ClinicalTrials.gov Identifier: NCT01889108
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : June 28, 2013
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date  ICMJE June 13, 2013
First Posted Date  ICMJE June 28, 2013
Last Update Posted Date June 28, 2013
Study Start Date  ICMJE July 2012
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2013)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2013)
Parent Child Interactions [ Time Frame: End of intervention at 3 months of adjusted age ]
Behavioral coding of parent child interactions
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility Study of SPEEDI
Official Title  ICMJE Feasibility Study of Supporting Play, Exploration, & Early Development Intervention (SPEEDI) for Infants Born Preterm
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Premature
Intervention  ICMJE Behavioral: SPEEDI
Behavior intervention combining parent education and physical therapy intervention for preterm infants
Other Name: Developed for this study
Study Arms  ICMJE
  • No Intervention: Control
    Usual care
  • Experimental: Intervention group
    Intervention with SPEEDI
    Intervention: Behavioral: SPEEDI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 27, 2013)
10
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01889108
Other Study ID Numbers  ICMJE VCU_HM13949
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Virginia Commonwealth University
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP