NCT03518736: TimeSPEEDI2

Does Timing Matter? Supporting Play, Exploration, and Early Developmental Intervention

Active, enrolled NA Last updated 16 April 2024

What this trial tests

NA trial testing Supporting Play Exploration and Developmental Intervention (SPEEDI) in Preterm Infant in 85 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

6 February 2019

Primary endpoint
1 July 2025

1 July 2025

Quick facts

Lead sponsor	University of Southern California
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	85
Start date	6 February 2019
Primary completion	1 July 2025
Estimated completion	1 July 2025
Sites	2 locations across United States

Drugs / interventions tested

• Supporting Play Exploration and Developmental Intervention (SPEEDI)

Conditions studied

• Preterm Infant — all drugs for Preterm Infant →
• Cerebral Palsy — all drugs for Cerebral Palsy →

Sponsor

University of Southern California

Who can join

Under 6 Months, any sex, with Preterm Infant or Cerebral Palsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Early developmental intervention programmes provided post hospital discharge to prevent motor and cognitive impairment in preterm infants.
   Orton J, Doyle LW, Tripathi T, Boyd R, et al · · 2024 · cited 37× · PMID 38348930 · DOI 10.1002/14651858.cd005495.pub5
2. Parent Experiences in the NICU and Transition to Home.
   Spence CM, Stuyvenberg CL, Kane AE, Burnsed J, et al · · 2023 · cited 30× · PMID 37297654 · DOI 10.3390/ijerph20116050
3. Emergent Prophylactic, Reparative and Restorative Brain Interventions for Infants Born Preterm With Cerebral Palsy.
   Finch-Edmondson M, Morgan C, Hunt RW, Novak I. · · 2019 · cited 29× · PMID 30745876 · DOI 10.3389/fphys.2019.00015
4. Efficacy of Supporting Play Exploration and Early Development Intervention in the First Months of Life for Infants Born Very Preterm: 3-Arm Randomized Clinical Trial Protocol.
   Dusing SC, Burnsed JC, Brown SE, Harper AD, et al · · 2020 · cited 27× · PMID 32329778 · DOI 10.1093/ptj/pzaa077
5. Gross Motor Function Measure-66 Item Sets for use with infants and toddlers at high risk for cerebral palsy: Construct validity and responsiveness.
   Koziol NA, Butera CD, Hsu LY, Pereira SA, et al · · 2025 · cited 4× · PMID 39951388 · DOI 10.1111/dmcn.16259
6. Effect of a NICU to Home Physical Therapy Intervention on White Matter Trajectories, Motor Skills, and Problem-Solving Skills of Infants Born Very Preterm: A Case Series.
   Butera CD, Rhee C, Kelly CE, Dhollander T, et al · · 2022 · cited 4× · PMID 36556244 · DOI 10.3390/jpm12122024
7. Factors Influencing Receipt and Type of Therapy Services in the NICU.
   Butera CD, Brown SE, Burnsed J, Darring J, et al · · 2023 · cited 3× · PMID 37366732 · DOI 10.3390/bs13060481
8. Longitudinal Changes in the Sensorimotor Pathways of Very Preterm Infants During the First Year of Life With and Without Intervention: A Pilot Study.
   Khurana S, Evans ME, Kelly CE, Thompson DK, et al · · 2021 · cited 2× · PMID 34160340 · DOI 10.1080/17518423.2021.1903602