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

Completed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT02153736

Run by

Virginia Commonwealth University

People needed

14

Starts

2014-04-01

Expected to finish

2016-10-01

Last updated by the study team

2018-01-29

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Genetic syndromes or musculoskeletal deformities

Where it is running

• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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