Early Developmental Intervention for Premature Babies
(TimeSPEEDI2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to help very premature babies (born before 29 weeks) improve motor and cognitive development. It tests an approach called Supporting Play Exploration and Developmental Intervention (SPEEDI), where parents work with therapists to learn how to engage and play with their babies to boost development. The goal is to determine if starting this intervention early, either while the baby is still in the hospital or shortly after going home, affects the baby’s growth. Babies born very early, with stable health, and living near the participating hospitals may be eligible to join. As an unphased trial, this study offers families the chance to contribute to groundbreaking research that could enhance early developmental support for premature infants.
Will I have to stop taking my current medications?
The trial information does not specify whether participants must stop taking their current medications.
What prior data suggests that this intervention is safe for premature babies?
Research shows that the Supporting Play Exploration and Developmental Intervention (SPEEDI) is generally safe for babies. Studies have not identified any serious side effects from this program. Previous research demonstrated that SPEEDI can aid in babies' development without causing harm. For example, in a controlled study, babies who participated in SPEEDI showed better interactions and improvements in movement and thinking skills.
No major safety issues have been reported. The program focuses on enhancing parent-baby interactions, which is naturally low-risk. It involves parents in guided play sessions to support their babies' growth, with assistance from a physical therapist. Overall, SPEEDI is considered a safe way to support early development in premature babies.12345Why are researchers excited about this trial?
Researchers are excited about the SPEEDI intervention for premature babies because it focuses on early developmental support through play and interaction, which is a shift from the more traditional focus on medical treatments and physical rehabilitation alone. Unlike standard care that often involves general health monitoring and physical therapy provided after discharge, SPEEDI offers a structured program involving direct collaboration between parents and physical therapists, starting either in the hospital or shortly after discharge. This hands-on approach aims to actively engage parents in their child's development, potentially leading to improvements in motor skills and cognitive development. By integrating personalized parental involvement with professional guidance, SPEEDI hopes to enhance developmental outcomes for premature infants, offering a more holistic and proactive strategy compared to usual care practices.
What evidence suggests that the SPEEDI intervention could be effective for improving motor and cognitive outcomes in very preterm infants?
Research has shown that the Supporting Play Exploration and Developmental Intervention (SPEEDI) can enhance movement and language skills in babies born prematurely. Studies have found that SPEEDI improves movement and cognitive skills by the time these babies reach 4 months old, adjusted for their early birth. Early results suggest that parental involvement in daily play and learning activities supports their baby's development. SPEEDI helps parents interpret their baby's signals and provide appropriate challenges, aiming to enhance movement and cognitive skills. In this trial, infants will begin SPEEDI either early, starting in the hospital, or later, at 4 months post-baseline. Both early and later initiation of SPEEDI have been linked to positive developmental effects.25678
Who Is on the Research Team?
Stacey Dusing, PT, PhD
Principal Investigator
University of Southern California
Are You a Good Fit for This Trial?
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 for a Trial Participant
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.
What Are the Treatments Tested in This Trial?
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