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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

Must not have

Diagnosis of a genetic syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a genetic syndrome.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Assessment of Problem Solving in Play

Gross Motor Function Measure (GMFM)

Test of Infant Motor Performance (TIMP)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 2Eligibility criteria met