NICU2HOME+ App for Premature Birth

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an app called NICU2HOME+ to determine its effectiveness in assisting parents of premature babies during and after their stay in the Neonatal Intensive Care Unit (NICU). The researchers aim to assess whether the app can improve parental confidence, address health equity, and potentially reduce hospital costs by decreasing the length of stay and readmission rates. The study includes two groups: one using the app and the other receiving standard care. This trial may suit parents with a premature baby born before 35 weeks who have stayed in the NICU for at least a week, particularly if they speak English or Spanish and own a smartphone. As an unphased trial, this study provides a unique opportunity for parents to contribute to innovative research that could enhance support for families with premature babies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the NICU2HOME+ app is safe for use with families of premature infants?

Research shows that the NICU2HOME+ app helps parents of premature babies by using mobile technology to offer education and support. Studies indicate that it is a safe tool.

The app builds on the NICU2HOME app, which has helped parents understand their baby's needs and the NICU environment. No reports of safety issues or negative effects have emerged from using the NICU2HOME+ app, suggesting it is well-received by users.

As a digital tool, the NICU2HOME+ app does not involve medication or medical procedures, resulting in a very low risk of physical side effects. Its main goal is to provide information and support, making it a low-risk choice for families in the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the NICU2HOME+ app because it offers a novel approach to supporting parents of premature infants. Unlike traditional methods that rely heavily on in-person consultations and printed materials, this app provides real-time, personalized guidance and resources directly to parents' smartphones. This digital approach not only enhances convenience and accessibility but also allows for ongoing support tailored to the unique needs of each family. By leveraging technology, the app aims to improve the transition from the NICU to home, potentially reducing stress and improving outcomes for both parents and their infants.

What evidence suggests that the NICU2HOME+ app is effective for supporting families of premature infants?

Research has shown that the NICU2HOME+ app, available to participants in this trial, can boost parents' confidence in caring for their premature babies. Parents using the app reported feeling more self-assured both in the hospital's neonatal intensive care unit (NICU) and after returning home. Another study found that the app helps parents prepare for their baby's discharge from the hospital. Although direct evidence of shorter hospital stays is limited, the app supports parents, which might indirectly lead to better outcomes for their babies. Overall, early research suggests the app could benefit families during this important transition period. ^{1 5 6 7 8}

Who Is on the Research Team?

Joshua Santiago, MA

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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

Smartphone owner

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)

My baby was born before 35 weeks of pregnancy.

Exclusion Criteria

Prisoners or other detained individuals

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04480255?tab=history&a=10

Record History | ver. 10: 2024-02-26 | NCT04480255 This table shows all the versions of this study record arranged in order by submitted date. To view one version of the study record, click the submitted ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10572298/

Development and Effects of Mobile-Application-Based ... This study used a nonequivalent control group non-synchronized design to develop and apply a parenting support app-based education program for premature ...

3. withpower.com withpower.com/trial/phase-premature-birth-7-2020-0f3ad

NICU2HOME+ App for Premature Birth · Info for Participants 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.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S002234762200004X

A Mobile Health Intervention to Support Parenting Self ... Parents assigned to use the NICU2HOME app reported greater parenting self-efficacy while in the neonatal intensive care unit and this continued once discharged ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5156477/

A pilot randomized control trial of a smartphone application A smartphone application used by parents of VLBW infants during the transition home from the NICU can improve parenting self-efficacy, discharge preparedness, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03505424?tab=history&a=9

Record History | ver. 9: 2024-05-06 | NCT03505424 NICU2HOME app was created for parents of premature infants to meet their demands. The app will teach parents about their baby and the NICU. It will allow ...

7. apps.apple.com apps.apple.com/cy/app/nicu2home/id1539096038

NICU2HOME on the App Store Created by a neonatal hospitalist and a leading team of designers, NICU2HOME is the first evidence-based and research-backed smartphone ...

8. aging.networkofcare.org aging.networkofcare.org/riverside/CommunityResources/ClinicalTrials/Detail/NCT04480255?keyword=%22Premature%22

NICU2HOME+: Supporting Illinois Families Mobile technology such as NICU2HOME+ offers an innovative way to reduce costs in two ways. First, parents who are better informed and supported, who feel more ...