CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 413 enrolled
Drug / intervention
Group 1: Standard of Care +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04480255
NCT04480255N/ACompleted

NICU2HOME+: Supporting Illinois Families of Premature Infants With Smartphone Technology

Northwestern University·interventional·Posted Jul 21, 2020·Updated Jul 28, 2025

In Brief

A clinical study evaluating Group 1: Standard of Care and Group 2: NICU2HOME+ app for Premature Birth and 3 related conditions. Completed, enrolled 413 participants across 3 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 21, 2020
Enrollment StartAug 3, 2020
Primary CompletionJul 23, 2025
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 5.9 years ago

Interventions

Group 1: Standard of Careother

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.

Group 2: NICU2HOME+ appother

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.