NICU2HOME+: Supporting Illinois Families

NCT04480255 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 413

Last updated 2025-07-28

No results posted yet for this study

Summary

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

Conditions

  • Premature Birth
  • NICU
  • Premature
  • Infant

Interventions

OTHER

Group 1: Standard of Care

Those who are in Group 1 will receive the usual care which includes: 1. a welcome packet from the nursing staff 2. access to their infant's medical team including doctors and nurse 3. opportunities to ask any questions and understand the care their baby is receiving through participation in daily work rounds or through setting up family meetings with the medical team.

OTHER

Group 2: NICU2HOME+ app

In addition to the usual care made available to Group 1 as described above, Group 2 parents will receive the smartphone app. Group 2 parents will be asked to download the NICU2HOME app.

Sponsors & Collaborators

Principal Investigators

  • Joshua Santiago, MA · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-03
Primary Completion
2025-07-23
Completion
2025-07-23

Countries

  • United States

Study Locations

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Entities

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 NCT04480255 on ClinicalTrials.gov