Early Developmental Intervention for Premature Babies
(TimeSPEEDI2 Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether participants must stop taking their current medications.
What data supports the effectiveness of the treatment Supporting Play Exploration and Developmental Intervention (SPEEDI) for premature babies?
Research shows that SPEEDI helps parents provide supportive opportunities for their babies' development, starting in the hospital and continuing at home, which can improve early reaching and problem-solving behaviors. Additionally, early interventions like SPEEDI have been shown to enhance motor and cognitive development in preterm infants.12345
Is the Early Developmental Intervention for Premature Babies safe?
How is the SPEEDI treatment different from other treatments for premature babies?
SPEEDI is unique because it combines early and intense intervention with family support, starting in the NICU and continuing at home, to enhance development in preterm infants. It focuses on supporting parents to provide developmentally supportive opportunities, which is different from other treatments that may not emphasize this continuous and family-centered approach.12348
What is the purpose of this trial?
Infants born very preterm (≤28 weeks of gestation) are at high risk of having developmental disabilities including cerebral palsy, coordination impairments, attention deficit and learning disabilities. Impairment including reduced postural control, movement variability, visual motor skills, and motor learning are common during the first months of life and are associated with later developmental disabilities. However, infant born very preterm rarely receive evidence based therapeutic intervention in the first months of life when basic science and animal intervention studies suggest the greatest efficacy. Barriers to enrollment in services delay the onset of services and delivery models rarely support targeted preventative intervention or enhanced parent engagement during in the transition from the neonatal intensive care unit (NICU) to home.Targeted intervention supporting postural control and motor learning in the NICU have resulted in short term motor gains. Interventions that enhance parent's ability to read their infant's cues and provide engagement opportunities improve maternal mental health and infant social and cognitive outcomes in the short-term. The purpose of this randomized clinical trial is to evaluate the efficacy of an intervention that combines evidence based motor intervention and parent engagement to enhance the parent's ability to provide daily motor and cognitive opportunities resulting in improved motor and cognitive outcomes.Supporting Play Exploration and Development Intervention (SPEEDI) uses guided participation to empower parents in reading infant's behavioral cues, identifying ideal times for interaction, and enriching the environment and learning opportunities. Parents participate in 5 session in 3 weeks while learning principles of engagement, readiness for interaction, and to provide early motor and cognitive learning opportunities. Parents provide 20 minutes of motor and cognitive play based enrichment daily for 12 weeks with bi-weekly physical therapist support. The parent is empowered to determine the infant's current abilities and advance the activities to the "Just Right Challenge" throughout the 12 weeks, likely continuing after the intervention.The efficacy of SPEEDI will be assessed during delivery at 2 time point; the transition from the NICU to home (around the infant's due date) and at 3-4 months of adjusted age (after the infants due date). Ninety infants will be randomly assigned to a Usual Care group, SPEEDI_Early, or SPEEDI_Later group. Group differences will be assessed in developmental outcomes on the motor and cognitive scales of the Bayley Scales for Infant and Toddler Development as well as the Early Problem Solving Indicator and Gross Motor Function Measure at the end of each intervention period, 12 and 24 months of age.
Research Team
Stacey Dusing, PT, PhD
Principal Investigator
University of Southern California
Eligibility Criteria
This trial is for very preterm infants (born ≤28 weeks of gestation) who are medically stable and off ventilator support by 42 weeks. It's also for parents or caregivers who speak English, live within 60 miles of the participating hospitals in Virginia, and have access to local Early Intervention services. Infants with unstable medical conditions after 42 weeks or diagnosed genetic syndromes cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
SPEEDI Intervention (Early)
Infants participate in the SPEEDI intervention starting in the hospital and lasting for 4 months, including 10 visits with a physical therapist and 12 weeks of parent daily intervention.
SPEEDI Intervention (Late)
Infants participate in the SPEEDI intervention starting at 4 months post baseline, including 10 visits with a physical therapist and 12 weeks of parent daily intervention.
Follow-up
Participants are monitored for developmental outcomes on the motor and cognitive scales of the Bayley Scales for Infant and Toddler Development, as well as other measures.
Treatment Details
Interventions
- Supporting Play Exploration and Developmental Intervention (SPEEDI)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Southern California
Lead Sponsor
National Institutes of Health (NIH)
Collaborator