NICU2HOME+ App for Premature Birth

Recruiting at 2 trial locations

Overseen By Jeff Loughead, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Craig Garfield

Disqualifiers: Non-adults, Cognitively impaired, Prisoners

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

413 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this project is to provide a stepwise, methodical approach to developing and testing the ability of Neonatal Intensive Care Unit 2 Home (NICU2HOME+) to support diverse Illinois families of premature infants during and after their Neonatal Intensive Care Unit (NICU) stays in an effort to address health equity, improve parenting, and reduce costs. There are 3 objectives of the study: 1) Identify and assess the requirements for expansion of NICU2HOME+, a suite of mobile patient education and engagement applications with Electronic Medical Record (EMR) integration that is culturally appropriate and customized to the needs of a diverse population of patients and families to 3 additional level III Illinois NICUS; 2) develop and deploy NICU2HOME+ to these 3 additional NICUs; and 3)determine if it is effective in: a) addressing health equity issues, b) improving parenting self-efficacy and satisfaction, and c) improving NICU outcomes such as a reduced length of stay and lower readmission rates that result in lower healthcare costs. All research recruitment and participation will take place in the following spaces: 1. Northwestern Medicine's Central DuPage Hospital (25 N.Winfield Rd., Winfield, IL)- NICU, Postpartum, and Research Offices 2. Northwest Community Hospital (800 W. Central Rd., Arlington Heights, IL)- NICU,Postpartum, and Research Offices 3. Rush University Medical Center (Chicago, IL)- NICU, Postpartum, and Research Offices

Research Team

Joshua Santiago, MA

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for families with infants born prematurely (before 35 weeks) who are admitted to specific NICUs in Illinois and have a minimum stay of 7 days. Parents must understand English or Spanish and own a smartphone. It excludes prisoners, detained individuals, and non-adults unable to consent.

Inclusion Criteria

My baby was born before 35 weeks of pregnancy.

I am fluent in English or Spanish.

Parents (including single parents) of premature infants (<35 weeks) admitted to Central Dupage Hospital (CDH), Northwest Community Hospital (NCH), and Rush University Medical Center (RUSH)

Exclusion Criteria

Prisoners or other detained individuals

I am unable to give consent due to age or cognitive impairment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

NICU Stay

Participants receive standard NICU care, with some using the NICU2HOME+ app

Varies based on infant's condition

Continuous stay in NICU

Post-Discharge Follow-up

Participants complete surveys at discharge, 14 days, and 30 days post-discharge

4 weeks

Surveys administered at specific intervals

Extended Follow-up

Optional interviews conducted to understand participants' experiences

Up to 1 year post-discharge

Treatment Details

Interventions

• NICU2HOME+ app
• Standard of Care

Trial Overview The study tests the NICU2HOME+ app against standard care for premature infants in the NICU. The app aims to support families by integrating with medical records, providing education, and addressing health equity. Its effectiveness on parenting, costs, and infant outcomes will be evaluated.

Participant Groups

Group I: Group 1: Standard of Care Active Control 1 Intervention

Parents of infants born from date July 2020-December 2020

Group II: Group 2: NICU2HOME+ app Active Control 1 Intervention

Parents of infants born from mid Jan 2021-May2021

Who Is Running the Clinical Trial?

Craig Garfield

Lead Sponsor

Trials

1

Recruited

410+

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Blue Cross Blue Shield

Collaborator

Trials

24

Recruited

273,000+