Feasibility Study of SPEEDI

NCT ID: NCT01889108

Last Updated: 2023-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-06-30

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.

Conditions

Premature

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group

Intervention with SPEEDI

Group Type: EXPERIMENTAL

SPEEDI

Intervention Type: BEHAVIORAL

Behavior intervention combining parent education and physical therapy intervention for preterm infants

Interventions

SPEEDI

Behavior intervention combining parent education and physical therapy intervention for preterm infants

Intervention Type: BEHAVIORAL

Other Intervention Names

Developed for this study

Eligibility 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

• Maximum Eligible Age: 34 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

VCU_HM13949

Identifier Type: -

Identifier Source: org_study_id