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Control Group for Motor Delay

N/A

Waitlist Available

Led By Raye-Ann deRegnier, MD

Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria Checklist

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

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-3 months

Awards & highlights

Study Summary

This trial is testing whether high-risk newborns referred to Early Intervention services after NICU discharge fare better when they promptly receive weekly post-discharge therapy vs. when they only receive care coordination.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2-3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-3 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

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

Test of Infant Motor Performance Score (TIMP)

Time to initiation of Early Intervention therapy services

Secondary outcome measures

General movements assessment-

Hammersmith Infant Neurologic examination

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Control GroupExperimental Treatment1 Intervention

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.

Group II: Intervention GroupActive Control2 Interventions

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor

256 Previous Clinical Trials

5,187,775 Total Patients Enrolled

2 Trials studying Motor Delay

342 Patients Enrolled for Motor Delay

Raye-Ann deRegnier, MDPrincipal InvestigatorLurie Children's Hospital

Frequently Asked Questions

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

Is enrollment still in progress for this investigation?

"As indicated on clinicaltrials.gov, this medical trial is currently open for participants with a posting date of February 23rd 2022 and an edit from April 5th 2022."

Answered by AI

Can I be a participant in this clinical experiment?

"This scientific investigation is open to 105 infants with motoric delays aged between 0 and 1 month old. To qualify, applicants must show signs of developmental hindrance (having already enrolled in an Early Childhood Clinic or receiving Illinois Early Intervention services), be less than 45 weeks post-menstrual age at discharge, possess a working knowledge of English language, and be identified and enrolled before NICU discharge."

Answered by AI

Does the age of participants factor into eligibility for this clinical experiment?

"Qualifying for this research study necessitates being between 0 and 1 month of age."

Answered by AI

What is the current enrollment for this research project?

"Affirmative. According to information published on clinicaltrials.gov, this medical trial is recruiting participants. It was first posted on February 23rd 2022 and the most recent update was made on April 5th of that year. This study requires 105 patients from 4 different locations for enrollment purposes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Project Initiate: Transition to Community Therapy Services After NICU Discharge

Raye Ann deRegnier 2022. "Project Initiate: Transition to Community Therapy Services After NICU Discharge". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05251051.