Overview

This trial is active, not recruiting.

Conditions infant, premature, diseases, brain white matter disease periventricular
Treatment speedi intervention
Sponsor Virginia Commonwealth University
Collaborator Foundation for Physical Therapy, Inc.
Start date April 2014
End date October 2016
Trial size 16 participants
Trial identifier NCT02153736, VCUIRB HM20001308

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(No Intervention)
This group of subjects will receive usual care provided in the medial system and community.
(Experimental)
This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.
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.

Primary Outcomes

Measure
Reaching (Toy contact duration)
time frame: 18 months
Early Problem Solving Indicator (EPSI)
time frame: 18 months

Secondary Outcomes

Measure
Early Feeding Skill Assessment (FES)
time frame: 18 months
Parent Child Early Relational Assessment (PCERA)
time frame: 2 years
Bayley Scales of Infant and Toddler Development (Bayley).
time frame: 24 months
Test of Infant Motor Performance (TIMP)
time frame: 18 months

Eligibility Criteria

Male or female participants up to 18 weeks old.

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

Additional Information

Official title Initial Efficacy Study of Supporting Play, Exploration, & Early Development Intervention (SPEEDI) - Phase 1 Clinical Trial
Principal investigator Stacey C Dusing, PhD PT
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Virginia Commonwealth University.