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Early Developmental Intervention for Premature Babies (TimeSPEEDI2 Trial)

N/A

Waitlist Available

Led By Stacey Dusing, PT, PhD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A parent or LRA who speaks English and will be a caregiver for the enrolled infant

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

TimeSPEEDI2 Trial Summary

This trial is designed to study whether targeted intervention and engagement can improve motor and cognitive outcomes for infants born very preterm.

Who is the study for?

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.Check my eligibility

What is being tested?

The SPEEDI program is being tested to see if it helps improve motor and cognitive outcomes in very preterm infants. Parents learn to engage their babies through play-based enrichment activities daily for 12 weeks with guidance from physical therapists. The study compares usual care with early or later intervention using SPEEDI.See study design

What are the potential side effects?

Since this intervention involves parent education and infant engagement without medical drugs, there are no direct side effects like those seen with medication. However, individual experiences may vary based on the infant's condition and family dynamics.

TimeSPEEDI2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an English-speaking parent or legal guardian who will care for the enrolled infant.

TimeSPEEDI2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Bayley Scaled of Infant and Toddler Development Cognitive and Gross Motor Scaled Scores

Secondary outcome measures

Assessment of Problem Solving in Play

Gross Motor Function Measure (GMFM)

Test of Infant Motor Performance (TIMP)

TimeSPEEDI2 Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: SPEEDI_LateExperimental Treatment1 Intervention

Infants randomly assigned to this arm will participate in the SPEEDI intervention starting at 4 months post baseline or approximately 3 months after discharge from the hospital. This intervention includes 10 visits with a physical therapist and parent working together to advance an intervention program and 12 weeks of parent daily intervention. In addition they will continue with any intervention in the community recommended by their health care team.

Group II: SPEEDI_EarlyExperimental Treatment1 Intervention

Infants randomly assigned to this arm will participate in the SPEEDI intervention starting in the hospital and lasting for 4 months. This intervention includes 10 visits with a physical therapist and parent working together to advance an intervention program and 12 weeks of parent daily intervention. In addition they will continue with any intervention in the community recommended by their health care team.

Group III: Usual CareActive Control1 Intervention

Infants randomly assigned to this arm will not receive any study intervention but will continue with any intervention in the community recommended by their health care team.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,494 Total Patients Enrolled

7 Trials studying Cerebral Palsy

988 Patients Enrolled for Cerebral Palsy

University of Southern CaliforniaLead Sponsor

905 Previous Clinical Trials

1,596,193 Total Patients Enrolled

9 Trials studying Cerebral Palsy

315 Patients Enrolled for Cerebral Palsy

Stacey Dusing, PT, PhDPrincipal Investigator - University of Southern California

University of Southern California

Media Library

Supporting Play Exploration and Developmental Intervention (SPEEDI) Clinical Trial Eligibility Overview. Trial Name: NCT03518736 — N/A

Cerebral Palsy Research Study Groups: Usual Care, SPEEDI_Early, SPEEDI_Late

Cerebral Palsy Clinical Trial 2023: Supporting Play Exploration and Developmental Intervention (SPEEDI) Highlights & Side Effects. Trial Name: NCT03518736 — N/A

Supporting Play Exploration and Developmental Intervention (SPEEDI) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03518736 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there current openings in this clinical research study?

"Affirmative. The official clinicaltrials.gov page states that the trial, which was initially announced on February 6th 2019 and last edited on November 24th 2021, is currently recruiting patients. 90 participants are needed at one medical centre for this research to be successful."

Answered by AI

What is the aggregate size of this research cohort?

"Affirmative. Clinicaltrials.gov's records indicate that this research, which was initially posted on February 6th of 2019, is still recruiting participants. 90 individuals are required to take part in the study from one medical venue."

Answered by AI

Recent research and studies

Physical TherapyJournal

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, Stacey C, Jennifer C Burnsed, Shaaron E Brown, Amy D Harper, Karen D Hendricks-Munoz, Richard D Stevenson, Leroy R Thacker II, and Rebecca M Molinini. 2020. “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”. Physical Therapy. Oxford University Press (OUP). doi:10.1093/ptj/pzaa077.

Physical TherapyJournal

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

clinicaltrials.govStudy

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

Stacey Dusing 2019. "Does Timing Matter? Supporting Play, Exploration, and Early Developmental Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03518736.

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