Project Initiate: Transition to Community Therapy Services After NICU Discharge

NCT05251051 | Completed

• 1 other identifier: 2021-4541
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (3)

• Test of Infant Motor Performance Score (TIMP)

  The TIMP is a motor evaluation conducted by a physical therapist. The test is scored and the scores are converted to standard deviations based on the child's age. Changes in the infant's TIMP standard deviation score from discharge to 3 months of age, corrected for prematurity, assessed by an physical therapist blinded to the intervention group.

  2-3 months (discharge to first developmental clinic visit)

• Time to initiation of Early Intervention therapy services

  The time from discharge to the first Early Intervention home therapy service will be assessed

  Discharge to EI initiation (1-6 months)

• Parent quality of life questionnaire assessed using the Peds QL Family Impact Module

  Parent quality of life will be assessed at the beginning and end of the study. This test asks parents to rate their quality of life in 6 categories. Each item is scored on a Likert Scale from 0-4 and then reverse transformed to a score from 0-100. The investigators will use an overall score averaged from the 6 categories as an outcome, as well as scores for the individual categories. Higher scores indicated better parent reported quality of life.

  2-3 months

Secondary Outcomes (2)

• General movements assessment-

  At 3 months corrected age

• Hammersmith Infant Neurologic examination

  At 3 months corrected age

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

At NICU discharge, infants will be referred to Illinois Early Intervention. A coordinator (the navigator) will assist families in engaging with Early Intervention and completing all enrollment requirements. At NICU discharge, infants will be provided with standard home pediatric therapy services weekly for up to 14 weeks. These will be initiated within 2 weeks of discharge.

Behavioral: pediatric physical therapy; Other: Care Coordination

Control Group

OTHER

At NICU discharge, infants will be referred to Illinois Early Intervention. A coordinator (the navigator) will assist families in engaging with Early Intervention and completing all enrollment requirements. If transitional services were recommended by the NICU providers, the navigator will help families identify these services and obtain the necessary referrals.

Other: Care Coordination

Interventions

pediatric physical therapy BEHAVIORAL

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

Intervention Group

Care Coordination OTHER

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

Also known as: Navigation

Control Group; Intervention Group

Eligibility Criteria

• Age: 1 Day - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• At-risk for developmental impairments (enrolled in Early Childhood Clinic and are automatically eligible for Illinois Early Intervention services)
• Less that 45 weeks post-menstrual age (PMA) at discharge
• English-speaking
• Able to be identified and enrolled before discharge from the NICU

You may not qualify if:

• Children in DCFS custody or children of parents who decline therapy services through the State of Illinois Early Intervention Program.

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• University of Illinois at Chicago: collaborator
• University of Chicago: collaborator

Study Sites (4)

University of Illinois at Chicago

Chicago, Illinois, 60607, United States

Location

Lurie Children's Hospital

Chicago, Illinois, 60611, United States

Location

Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Psychomotor Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Raye-Ann deRegnier, MD

  Lurie Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes will be assessed by blinded neuromotor examiners.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: Infants will be assigned to an intervention or control group based on the city of residence at discharge (Chicago or not-Chicago)

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 22, 2022
• Study Start: February 23, 2022
• Primary Completion: June 27, 2024
• Study Completion: September 30, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)