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Completed

NCT Number: NCT01889108

Feasibility Study of SPEEDI

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.

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Key information

Conditions

Premature Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 34 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPEEDI

Behavioral

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

Other names: Developed for this study

Primary outcomes

  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 outcomes

  1. Parent Child Interactions

    Time frame: End of intervention at 3 months of adjusted age

    Behavioral coding of parent child interactions

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

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

Acronym: SPEEDI

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 28, 2013
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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