N/A
N=14
Initial Efficacy Study of Supporting Play, Exploration, & Early Development Intervention
Infant, Premature, Diseases · Brain White Matter Disease Periventricular
Bottom Line
View on ClinicalTrials.gov: NCT02153736 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Reaching (Toy Contact Duration) — 20.2; 28.02 Seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SPEEDI Intervention (Behavioral)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reaching (Toy Contact Duration) |
20.2; 28.02 | — |
| PRIMARY Early Problem Solving Indicator (EPSI) |
58.00; 103.2; 95.2; 131.80; 146; 212 | — |
| SECONDARY Early Feeding Skill Assessment (FES) |
8.32; 8.61; 8.27; 8.82; 8.00; 9.65 | — |
| SECONDARY Parent Child Early Relational Assessment (PCERA) |
0.27; 0.13; 0.20; 0.38; 0.34; 0.25 | — |
| SECONDARY Bayley Scales of Infant and Toddler Development (Bayley). |
79.6; 98.6; 80.0; 91.0; 89.0; 98.2 | — |
| SECONDARY Test of Infant Motor Performance (TIMP) |
54; 61; 82; 99 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02153736). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.