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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-10-31

Brief Summary

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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.

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Detailed Description

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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. The secondary aim is to assess the efficacy potential of SPEEDI to impact motor and cognitive development as assessed using commonly used clinical outcome measures. The exploratory aims are to assess the impact of SPEEDI on parent child interactions and feeding skills. The findings will provide crucial initial efficacy estimates to be used in a larger definitive clinical trial of SPEEDI.

Conditions

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Infant, Premature, Diseases Brain White Matter Disease Periventricular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual Care Group

This group of subjects will receive usual care provided in the medial system and community.

Group Type NO_INTERVENTION

No interventions assigned to this group

SPEEDI Intervention

This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.

Group Type EXPERIMENTAL

SPEEDI Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* born extremely preterm (˂29 weeks of gestation) OR 10 born preterm and diagnosed with a neonatal brain injury including intraventricular hemorrhage grade 3 or 4, periventricular white matter injury, or hydrocephalus requiring a shunt.
* Medically stable by 40 weeks of gestation, including being off ventilator support
* Live within 50 minutes of the hospital.
* English Speaking mother
* Mother willing and able to participate in the study with the infant subject