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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

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.

Condition or disease Intervention/treatment Phase
Premature Behavioral: SPEEDI Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Feasibility Study of Supporting Play, Exploration, & Early Development Intervention (SPEEDI) for Infants Born Preterm
Study Start Date : July 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : June 2013

Arm Intervention/treatment
No Intervention: Control
Usual care
Experimental: Intervention group
Intervention with SPEEDI
Behavioral: SPEEDI
Behavior intervention combining parent education and physical therapy intervention for preterm infants
Other Name: Developed for this study




Primary Outcome Measures :
  1. 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

  2. Problem Solving Behaviors [ Time Frame: end of intervention at 3 months of adjusted age ]
    Early infant problem solving

  3. Reaching [ Time Frame: end of intervention at 3 months of adjusted age ]
    Reaching and object interaction measures


Secondary Outcome Measures :
  1. Parent Child Interactions [ Time Frame: End of intervention at 3 months of adjusted age ]
    Behavioral coding of parent child interactions



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889108


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01889108    
Other Study ID Numbers: VCU_HM13949
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: June 28, 2013
Last Verified: June 2013
Keywords provided by Virginia Commonwealth University:
Premature
Development
Motor
Cognitive
Parent
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications