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Initial Efficacy Study of Supporting Play, Exploration, & Early Development Intervention

NCT02153736 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2018-01-29

Study results available
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Summary

The primary aims of this randomized controlled trial are to evaluate efficacy potential of SPEEDI at enhancing reaching and play based problem solving compared to infants receiving usual care.

Conditions

  • Infant, Premature, Diseases
  • Brain White Matter Disease Periventricular

Interventions

BEHAVIORAL

SPEEDI Intervention

Behavioral intervention provided through a collaboration between the mother of enrolled subjects and a physical therapist. Intervention starts in the Neonatal Intensive Care Unit and continues after discharge. SPEEDI includes both parent education and developmental activities.

Sponsors & Collaborators

  • Foundation for Physical Therapy, Inc.

    collaborator INDUSTRY

  • Children's Hospital Foundation

    collaborator OTHER

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Stacey C Dusing, PhD PT · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
18 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02153736 on ClinicalTrials.gov