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Project Initiate: Transition to Community Therapy Services After NICU Discharge

NCT05251051 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2024-12-13

No results posted yet for this study

Summary

Project Initiate is a pilot study of early neuromotor outcomes in high risk newborn infants who are referred to Early Intervention services after NICU discharge. The investigators hypothesize that infants with Medicaid insurance who have prompt access to weekly post-discharge therapy services will have better early neuromotor function at 3 months corrected age and better parent satisfaction than infants who receive only care coordination to help with Early Intervention enrollment and locating outpatient transitional services as indicated.

Conditions

  • Motor Delay

Interventions

BEHAVIORAL

pediatric physical therapy

Pediatric physical therapists will provide weekly home therapy using standard of care/best evidence procedures

OTHER

Care Coordination

A navigator will be assigned who will assist families in obtaining Early Intervention services and other therapy services if needed

Sponsors & Collaborators

  • University of Illinois at Chicago

    collaborator OTHER

  • University of Chicago

    collaborator OTHER

  • Ann & Robert H Lurie Children's Hospital of Chicago

    lead OTHER

Principal Investigators

  • Raye-Ann deRegnier, MD · Lurie Children's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-23
Primary Completion
2024-06-27
Completion
2024-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05251051 on ClinicalTrials.gov