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

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Infant, Premature, Diseases; Brain White Matter Disease Periventricular

Treatments: Behavioral: SPEEDI Intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02153736

HM20001308

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 14 patients

Sex: All

Ages: Under 18 weeks old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Genetic syndromes or musculoskeletal deformities

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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14 participants in 2 patient groups

Usual Care Group

No Intervention group

Description:

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

SPEEDI Intervention

Experimental group

Description:

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

Treatment:

Behavioral: SPEEDI Intervention