Feasibility Study of SPEEDI

Premature Clinical Trial

— SPEEDI  

Official title:

Feasibility Study of Supporting Play, Exploration, & Early Development Intervention (SPEEDI) for Infants Born Preterm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01889108
• Other study ID #: VCU_HM13949
• Status: Completed
• Phase: Phase 1
• Start date: July 2012
• Est. completion date: June 2013

Study information

• Verified date: August 2023
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 34 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature
• Premature Birth

Intervention

Behavioral:
• SPEEDI
Behavior intervention combining parent education and physical therapy intervention for preterm infants

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test of Infant Motor Performance	Assessment of motor development	Change from baseline to the end of intervention at 3 months of adjusted age
Primary	Problem Solving Behaviors	Early infant problem solving	end of intervention at 3 months of adjusted age
Primary	Reaching	Reaching and object interaction measures	end of intervention at 3 months of adjusted age
Secondary	Parent Child Interactions	Behavioral coding of parent child interactions	End of intervention at 3 months of adjusted age