Clinical trial NCT02153736: Initial Efficacy Study of Supporting Play, Exploration, & Early Development Intervention
Official title: Initial Efficacy Study of Supporting Play, Exploration, & Early Development Intervention (SPEEDI) - Phase 1 Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature, Diseases
Brain White Matter Disease Periventricular
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Foundation for Physical Therapy, Inc.
name: Children's Hospital Foundation
First posted: 2014-06-03
Enrollment: 14
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reaching (Toy Contact Duration)
timeFrame: 1 month post intervention
measure: Early Problem Solving Indicator (EPSI)
timeFrame: End of intervention, 1 and 3 months post intervention
Secondary outcomes:
measure: Early Feeding Skill Assessment (FES)
timeFrame: Baseline, End phase 1, End of intervention, 1 and 3 months post intervention
measure: Parent Child Early Relational Assessment (PCERA)
timeFrame: Baseline, End phase 1, End of intervention, 1 month post intervention
measure: Bayley Scales of Infant and Toddler Development (Bayley).
timeFrame: 3 month post intervention
measure: Test of Infant Motor Performance (TIMP)
timeFrame: Baseline to End of intervention
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Stacey C Dusing, PhD PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dusing SC, Tripathi T, Marcinowski EC, Thacker LR, Brown LF, Hendricks-Munoz KD. Supporting play exploration and early developmental intervention versus usual care to enhance development outcomes during the transition from the neonatal intensive care unit to home: a pilot randomized controlled trial. BMC Pediatr. 2018 Feb 9;18(1):46. doi: 10.1186/s12887-018-1011-4.