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NCT03518736 · ClinicalTrials.gov registry record · NA
Does Timing Matter? Supporting Play, Exploration, and Early Developmental Intervention
A NA study of Cerebral Palsy and Preterm Infant, sponsored by University of Southern California.
- Active
- Registry status
- NA
- Development phase
- 85
- Enrollment target
- 2
- Study locations
NCT03518736 is a NA study of Cerebral Palsy and Preterm Infant that is active but no longer recruiting, run by University of Southern California. The registered enrollment target is 85 participants, below the 229-participant average among 91 other Cerebral Palsy trials with a reported enrollment target (63% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT03518736, a NA study of Cerebral Palsy and Preterm Infant, is active but no longer recruiting, sponsored by University of Southern California.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 85 participants
- Enrollment target
- 2
- Study locations
Study Summary
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-we
Conditions Studied
Interventions
- BEHAVIORAL Supporting Play Exploration and Developmental Intervention (SPEEDI)
Study Locations (2)
California
- University of Southern California - Los Angeles
Virginia
- Virginia Commonwealth University - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2019-02-06 |
| Est. Completion | 2025-07-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03518736
The ClinicalTrials.gov registry entry for NCT03518736 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 229-participant average among 91 other Cerebral Palsy trials with a reported enrollment target (63% lower). The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cerebral Palsy appearing as the primary indexed condition, and to 1 intervention - of which Supporting Play Exploration and Developmental Intervention (SPEEDI) is the first listed.
NCT03518736 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Virginia.
Frequently Asked Questions
What is clinical trial NCT03518736 about?
NCT03518736 is a clinical study titled "Does Timing Matter? Supporting Play, Exploration, and Early Developmental Intervention". 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 moto...
What is the current status of trial NCT03518736?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 85 participants. The study started on 2019-02-06. Estimated completion is 2025-07-01.
What conditions does trial NCT03518736 study?
This clinical trial studies the following conditions: Cerebral Palsy, Preterm Infant.
What interventions are being tested in trial NCT03518736?
The interventions under investigation include: Supporting Play Exploration and Developmental Intervention (SPEEDI) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03518736?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03518736 being conducted?
This trial has 2 study locations across California, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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