Premature BirthNCT04480255
NICU2HOME+: Supporting Illinois Families
A study testing Group 2: NICU2HOME+ app in people with Premature Birth and NICU, run by Northwestern University at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Premature Birth, NICU, Premature
- What is being tested?
- Group 2: NICU2HOME+ app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 413 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Aug 2020to 23 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
- Infants born prematurely with a gestational age of <35 weeks
- Minimum stay in NICU of 7 days
- Competent in English or Spanish (i.e. to fully understand the questions asked in the surveys)
- Smartphone owner
Who cannot join
- Non-adults unable to consent/Cognitively Impaired
- Prisoners or other detained individuals
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northwest Community Hospital
Arlington Heights, Illinois, 60005
Rush University Medical Center
Chicago, Illinois, 60612
Centra Dupage Hospital
Winfield, Illinois, 60192
About this study
Official title: NICU2HOME+: Supporting Illinois Families of Premature Infants With Smartphone Technology
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:
- Northwestern Medicine's Central DuPage Hospital (25 N.Winfield Rd., Winfield, IL)- NICU, Postpartum, and Research Offices
- Northwest Community Hospital (800 W. Central Rd., Arlington Heights, IL)- NICU,Postpartum, and Research Offices
- Rush University Medical Center (Chicago, IL)- NICU, Postpartum, and Research Offices
Read the detailed description
The investigators propose to address the goals of the Affordability Cures Initiative and promote health equity by developing NICU2HOME+, a smartphone app designed to support NICU parents in a culturally appropriate manner in community level III NICUs in Illinois and to include EMR integration. 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 confident and competent in caring for their premature infants, may be more prepared for an earlier discharge. Second, cost savings may be realized after discharge, if better educated and more competent parents are less likely to inappropriately visit the ER or their infant's physicians as they know what to expect and can provide better, more competent care to their baby. At its center, NICU2HOME+is able to achieve four "rights" of adaptive personalization and parent-centric care: delivering the "right" information at the "right" time to the "right" person via the "right" medium. The ultimate goal of this proposal, therefore, is to develop a scalable, evidence-based.
Participants will be divided into two research groups based on when their infant was born. The first group, parents of infants born between June 15th and December 31st 2020, will receive the standard care provided in the NICU. The second group of participants, those with infants born between January 1 and July 31 2021, will also receive the NICU standard care and additionally be asked to use a smartphone app related to NICU and at-home care. Participation in the second groups requires ownership of a smartphone and the ability to use a smartphone app.
If the participant has been assigned to the first group, the investigators would like both parents to participate in the study independently and therefore complete individual consent forms. However, the investigators recognize not all families will have two parents that are interested or able to participate and ultimately participation from some families will include only one parent.
As part of the study, participants will be asked to complete four surveys. They will be administered at the time of admission, infant's discharge from the NICU, fourteen days after discharge and thirty days after discharge. For those families who have a longer stay in the NICU, the investigators will ask parents to complete two additional surveys; one 30 days after admission and one 60 days after admission.Each survey will take approximately five to ten minutes to complete. The main benefit of participation is that this research that may help improve the NICU experience for other families in the future. The primary risk of participation is the potential loss of confidentiality, but strict measures are in place to minimize the chance of this happening.
In addition, if participants agree to the option at the end of this Consent Form, participants may or may not be invited to participate in a separate research interview to take place during the participants NICU stay, around the time of the infant's discharge from the hospital, or within a year of the transition to home. These optional, voluntary interviews will be conducted at a time, location and method (phone or in-person) agreed upon by the parent. All interviews will be conducted with our research staff with experience interviewing parents of NICU graduates. While the investigators encourage both parents to participate in order to hear about differences in experiences, one or both parents can ultimately participate. The purpose of the research interview is to better understand participants' experience in the NICU and at home as the parent of a premature infant.
Participants will be divided into two research groups based on when their infant was born. The first group, parents of infants born between July 15th and December 31st 2020, will receive the standard care provided in the NICU. The second group of participants, those with infants born between January 1 and July 31 2021, will also receive the NICU standard care and additionally be asked to use a smartphone app related to NICU and at-home care. Participation in the second groups requires ownership of a smartphone and the ability to use a smartphone app.
If a participants are assigned to the first or second groups, the investigators would like both parents to participate in the study independently and therefore complete individual consent forms. However, the investigators recognize not all families will have two parents that are interested or able to participate and ultimately participation from some families will include only one parent.
As part of the study, participants will be asked to complete four surveys. They will be administered at the time of admission, infant's discharge from the NICU, fourteen days after discharge and thirty days after discharge. For those families who have a longer stay in the NICU, the investigators will ask parents to complete two additional surveys; one 30 days after admission and one 60 days after admission. Each survey will take approximately five to ten minutes to complete. The main benefit of participation is that this research that may help improve the NICU experience for other families in the future. The primary risk of participation is the potential loss of confidentiality, but strict measures are in place to minimize the chance of this happening.
In addition, if participants agree to the option at the end of this Consent Form, participants may or may not be invited to participate in a separate research interview to take place during the participants' NICU stay, around the time of the participants' infant's discharge from the hospital, or within a year of the participants transition home. These optional, voluntary interviews will be conducted at a time, location and method (phone or in-person) agreed upon by the parent. All interviews will be conducted with our research staff with experience interviewing parents of NICU graduates. While the investigators encourage both parents to participate in order to hear about differences in experiences, one or both parents can ultimately participate. The purpose of the research interview is to better understand the participants' experience in the NICU and at home as the parent of a premature infant.
Optional Interview:
In addition to the intervention study, optional qualitative interviews will be conducted with participants using a maximum variability approach. Interviews will focus on the following:
- Their overall experience of using the app
- Educational Content
- Relationship/communication through app with extended family/friends
- Readiness for discharge
- Empowerment, ability to communicate better with doctors and nurses, and being able to participate in child health care confidently
- Being ready to go home and did the app help
- Information, communication and support needs across the NICU stay, discharge and beyond
This voluntary interview will be described to parents at the time of consent. To maintain confidentiality all subjects will be given a unique study code (PIN) and all information collected for app development will be linked to that number, not to any other identifier. All documents that include identifiers will be stored in a locked, secure location that only key authorized study personnel (e.g. PI, research team members) will have access to.
The interviews will be audio recorded. The recordings will be given an Identification (ID) number and kept in locked cabinets and on secure computers. The audio recordings will be transcribed and kept on password protected computers. (There will be no personal identifiers (such as names) in the transcribed documents.) After the recordings are transcribed, the audio files will be erased.
Only the people listed on the Authorized Research Personnel list will have access to the data. All paper data will be kept in locked files and rooms. Electronic data will be kept in on password- encrypted computers and files with identifying information will be individually password protected. Names and contact information will be stored only for the purpose of contacting participants. This information will be stored separately from study data and the two will only be linked by a study ID, kept in a password protected document. Upon completion of data collection all name and contact information as will be destroyed by file deletion. All data collected for this study will be kept in a locked, secure location and anything that can be destroyed (deleted, shredded, etc.) after it has been coded, will be.
- Conditions
- Premature Birth, NICU, Premature, Infant
- Being tested
- Group 1: Standard of Care, Group 2: NICU2HOME+ app
- Keywords
- Premature Infant; NICU, Premature Birth, Smartphone App, NICU
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: Standard of CareOther
Those who are in Group 1 will receive the usual care which includes:
- a welcome packet from the nursing staff
- access to their infant's medical team including doctors and nurse
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Standard of Care | Active comparator | Parents of infants born from date July 2020-December 2020 Receives: Other: Group 1: Standard of Care |
| Group 2: NICU2HOME+ app | Active comparator | Parents of infants born from mid Jan 2021-May2021 Receives: Other: Group 2: NICU2HOME+ app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobile Application Outcome 1
The primary outcome measure understand how the smartphone application improves patient/parent experiences in the NICU. This will be measured through a survey.
Measured: 2-3 months
Mobile Application Outcome 2
The primary outcome measure will addressing the association of the smartphone application with parenting self-efficacy to improve infants' and parents' health outcomes. This will be measured through a survey.
Measured: 2-3 months
Secondary outcomes (13)
State-Trait Anxiety Inventory (STAI)
Patient anxiety will be measured through a survey. The response options range from 1 to 4 (Almost never, Sometimes, Often, and Almost always)
Measured: 2-3 months
Parenting Sense of Competence Scale (PSOC)
Self-efficacy will be measured through a survey. The response options range from 1 to 6 (Strongly Disagree to Strongly Agree)
Measured: 2-3 months
Edinburgh Postnatal Depression Scale (EPDS)
Depression will be measured through a survey. The response options range from 0 (for example, no, not at all or no, never again) to 3 (for example, yes, most of the time or yes, very often). The total score ranges from 0 to 30, where higher values indicate more severe symptoms of depression.
Measured: 2-3 months
Press Ganey Questionnaire (PG)
Measures all aspects of patient satisfaction during hospital stay.
Measured: 2-3 months
Healthcare encounters (HE)
Patient satisfaction of healthcare provider's will be measured through survey.
Measured: 2-3 months
Readmission rate (RR)
Readmission rates will be measured through a survey.
Measured: 2-3 months
User Version of the Mobile Application Rating Scale (uMARS)
Quality and reliability of mobile application will be measured through a survey. All items are rated on a 5-point scale from "1. Inadequate" to "5. Excellent"
Measured: 2-3 months
Perinatal PTSD Questionnaire - Modified (PPQ-M)
Perinatal Post-Traumatic Stress Disorder (PTSD) will be measured through a survey.
Measured: 2-3 months
Coronavirus disease 2019 (COVID-19) Impact Scale
Given the uncertainty of the global pandemic, we measuring if COVID will have an impact on the use of the mobile application. This scale is measured on a scale from 1-4 (No Change to Severe), with higher scores mean a worse outcome.
Measured: 2-3 months
Perceived Stress Scale (PSS)
Stress will be measured through a survey. The response options range from 1 to 4 (Never Almost; Never Sometimes; Fairly Often; Very Often). The total score ranges from 0 to 16, where higher values indicate more severe symptoms of stress.
Measured: 2-3 months
MOS- Social Support Scale (MOS)
Social Support will be measured through a survey. The response options range from 1 to 5 (None of the time - All of the time). The survey consists of four separate social support subscales and an overall functional social support index. A higher score for an individual scale or for the overall support index indicates more support.
Measured: 2-3 months
Health Behavior (HB)
Health behavior questions relating to physical health, mental health, stress, breastfeeding, and reproductive health will be measured through a survey.
Measured: 2-3 months
Centers for Disease Control (CDC) - Hear Her Campaign
Questions surrounding maternal mortality and morbidity will be asked through a survey.
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start3 Aug 2020
- Primary completion23 Jul 2025
- Study completion23 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 413 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Cross Blue Shield
- Responsible party
- Principal investigator, Craig Garfield, Northwestern University
- Investigators
- Joshua Santiago, MA, Study director, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480255
- Sponsor's protocol ID
- STU00212196
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2020
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Institute of Medicine (US) Committee on Understanding Premature Birth and Assuring Healthy Outcomes; Behrman RE, Butler AS, editors. Preterm Birth: Causes, Consequences, and Prevention. Washington (DC): National Academies Press (US); 2007. Available from http://www.ncbi.nlm.nih.gov/books/NBK11362/
PubMed 20669423Garfield CF, Lee Y, Kim HN. Paternal and maternal concerns for their very low-birth-weight infants transitioning from the NICU to home. J Perinat Neonatal Nurs. 2014 Oct-Dec;28(4):305-12. doi: 10.1097/JPN.0000000000000021.
PubMed 24927295Braveman P. What is health equity: and how does a life-course approach take us further toward it? Matern Child Health J. 2014 Feb;18(2):366-72. doi: 10.1007/s10995-013-1226-9.
PubMed 23397099Blumenshine P, Egerter S, Barclay CJ, Cubbin C, Braveman PA. Socioeconomic disparities in adverse birth outcomes: a systematic review. Am J Prev Med. 2010 Sep;39(3):263-72. doi: 10.1016/j.amepre.2010.05.012.
PubMed 20709259MacDorman MF. Race and ethnic disparities in fetal mortality, preterm birth, and infant mortality in the United States: an overview. Semin Perinatol. 2011 Aug;35(4):200-8. doi: 10.1053/j.semperi.2011.02.017.
PubMed 21798400Pew Research Center: Internet Science & Technology. Mobile technology fact sheet. 2018; http://www.pewinternet.org/fact-sheet/mobile/. Accessed January 14, 2019, 2015.
Anderson-Lewis C, Darville G, Mercado RE, Howell S, Di Maggio S. mHealth Technology Use and Implications in Historically Underserved and Minority Populations in the United States: Systematic Literature Review. JMIR Mhealth Uhealth. 2018 Jun 18;6(6):e128. doi: 10.2196/mhealth.8383.
PubMed 29914860Anoshiravani A, Gaskin G, Kopetsky E, Sandborg C, Longhurst CA. Implementing an Interoperable Personal Health Record in Pediatrics: Lessons Learned at an Academic Children's Hospital. J Particip Med. 2011 Jul 10;3:e30.
PubMed 21853160Cooper LG, Gooding JS, Gallagher J, Sternesky L, Ledsky R, Berns SD. Impact of a family-centered care initiative on NICU care, staff and families. J Perinatol. 2007 Dec;27 Suppl 2:S32-7. doi: 10.1038/sj.jp.7211840.
PubMed 18034178De Rouck S, Leys M. Information needs of parents of children admitted to a neonatal intensive care unit: a review of the literature (1990-2008). Patient Educ Couns. 2009 Aug;76(2):159-73. doi: 10.1016/j.pec.2009.01.014. Epub 2009 Mar 24.
PubMed 19321288Escobar GJ, Joffe S, Gardner MN, Armstrong MA, Folck BF, Carpenter DM. Rehospitalization in the first two weeks after discharge from the neonatal intensive care unit. Pediatrics. 1999 Jul;104(1):e2. doi: 10.1542/peds.104.1.e2.
PubMed 10390288Garfield CF, Lee YS, Kim HN, Rutsohn J, Kahn JY, Mustanski B, Mohr DC. Supporting Parents of Premature Infants Transitioning from the NICU to Home: A Pilot Randomized Control Trial of a Smartphone Application. Internet Interv. 2016 May;4(Pt 2):131-137. doi: 10.1016/j.invent.2016.05.004. Epub 2016 Jun 4.
PubMed 27990350Kim HN, Garfield C, Lee YS. Paternal and maternal information and communication technology usage as their very low birth weight infants transition home from the NICU. Int J Hum Comput Interact. 2015;31(1):44-54.
Lee Y, Garfield C, Massey N, Chaysinh S, Hassan S. NICU-2-home: Supporting the transition to home from the neonatal intensive care unit using a mobile application. Conference on Human Factors in Computing Systems; May 7 - 11,
Gilmore L, Cuskelly M. Factor structure of the Parenting Sense of Competence scale using a normative sample. Child Care Health Dev. 2009 Jan;35(1):48-55. doi: 10.1111/j.1365-2214.2008.00867.x. Epub 2008 Oct 22.
PubMed 18991983
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NICU2HOME+: Supporting Illinois Families of Premature Infants With Smartphone Technology
- ClinicalTrials.gov ID
- NCT04480255
- Acronym / sponsor ID
- STU00212196
- Conditions
- Premature Birth, NICU, Premature, Infant
- Keywords
- Premature Infant; NICU, Premature Birth, Smartphone App, NICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 413 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Blue Cross Blue Shield
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 23 Jul 2025 (actual)
- Study completion
- 23 Jul 2025 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Northwestern Medicine's Central DuPage Hospital (25 N.Winfield Rd., Winfield, IL)- NICU, Postpartum, and Research Offices
- Northwest Community Hospital (800 W. Central Rd., Arlington Heights, IL)- NICU,Postpartum, and Research Offices
- Rush University Medical Center (Chicago, IL)- NICU, Postpartum, and Research Offices
Detailed description
The investigators propose to address the goals of the Affordability Cures Initiative and promote health equity by developing NICU2HOME+, a smartphone app designed to support NICU parents in a culturally appropriate manner in community level III NICUs in Illinois and to include EMR integration. 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 confident and competent in caring for their premature infants, may be more prepared for an earlier discharge. Second, cost savings may be realized after discharge, if better educated and more competent parents are less likely to inappropriately visit the ER or their infant's physicians as they know what to expect and can provide better, more competent care to their baby. At its center, NICU2HOME+is able to achieve four "rights" of adaptive personalization and parent-centric care: delivering the "right" information at the "right" time to the "right" person via the "right" medium. The ultimate goal of this proposal, therefore, is to develop a scalable, evidence-based.
Participants will be divided into two research groups based on when their infant was born. The first group, parents of infants born between June 15th and December 31st 2020, will receive the standard care provided in the NICU. The second group of participants, those with infants born between January 1 and July 31 2021, will also receive the NICU standard care and additionally be asked to use a smartphone app related to NICU and at-home care. Participation in the second groups requires ownership of a smartphone and the ability to use a smartphone app.
If the participant has been assigned to the first group, the investigators would like both parents to participate in the study independently and therefore complete individual consent forms. However, the investigators recognize not all families will have two parents that are interested or able to participate and ultimately participation from some families will include only one parent.
As part of the study, participants will be asked to complete four surveys. They will be administered at the time of admission, infant's discharge from the NICU, fourteen days after discharge and thirty days after discharge. For those families who have a longer stay in the NICU, the investigators will ask parents to complete two additional surveys; one 30 days after admission and one 60 days after admission.Each survey will take approximately five to ten minutes to complete. The main benefit of participation is that this research that may help improve the NICU experience for other families in the future. The primary risk of participation is the potential loss of confidentiality, but strict measures are in place to minimize the chance of this happening.
In addition, if participants agree to the option at the end of this Consent Form, participants may or may not be invited to participate in a separate research interview to take place during the participants NICU stay, around the time of the infant's discharge from the hospital, or within a year of the transition to home. These optional, voluntary interviews will be conducted at a time, location and method (phone or in-person) agreed upon by the parent. All interviews will be conducted with our research staff with experience interviewing parents of NICU graduates. While the investigators encourage both parents to participate in order to hear about differences in experiences, one or both parents can ultimately participate. The purpose of the research interview is to better understand participants' experience in the NICU and at home as the parent of a premature infant.
Participants will be divided into two research groups based on when their infant was born. The first group, parents of infants born between July 15th and December 31st 2020, will receive the standard care provided in the NICU. The second group of participants, those with infants born between January 1 and July 31 2021, will also receive the NICU standard care and additionally be asked to use a smartphone app related to NICU and at-home care. Participation in the second groups requires ownership of a smartphone and the ability to use a smartphone app.
If a participants are assigned to the first or second groups, the investigators would like both parents to participate in the study independently and therefore complete individual consent forms. However, the investigators recognize not all families will have two parents that are interested or able to participate and ultimately participation from some families will include only one parent.
As part of the study, participants will be asked to complete four surveys. They will be administered at the time of admission, infant's discharge from the NICU, fourteen days after discharge and thirty days after discharge. For those families who have a longer stay in the NICU, the investigators will ask parents to complete two additional surveys; one 30 days after admission and one 60 days after admission. Each survey will take approximately five to ten minutes to complete. The main benefit of participation is that this research that may help improve the NICU experience for other families in the future. The primary risk of participation is the potential loss of confidentiality, but strict measures are in place to minimize the chance of this happening.
In addition, if participants agree to the option at the end of this Consent Form, participants may or may not be invited to participate in a separate research interview to take place during the participants' NICU stay, around the time of the participants' infant's discharge from the hospital, or within a year of the participants transition home. These optional, voluntary interviews will be conducted at a time, location and method (phone or in-person) agreed upon by the parent. All interviews will be conducted with our research staff with experience interviewing parents of NICU graduates. While the investigators encourage both parents to participate in order to hear about differences in experiences, one or both parents can ultimately participate. The purpose of the research interview is to better understand the participants' experience in the NICU and at home as the parent of a premature infant.
Optional Interview:
In addition to the intervention study, optional qualitative interviews will be conducted with participants using a maximum variability approach. Interviews will focus on the following:
- Their overall experience of using the app
- Educational Content
- Relationship/communication through app with extended family/friends
- Readiness for discharge
- Empowerment, ability to communicate better with doctors and nurses, and being able to participate in child health care confidently
- Being ready to go home and did the app help
- Information, communication and support needs across the NICU stay, discharge and beyond
This voluntary interview will be described to parents at the time of consent. To maintain confidentiality all subjects will be given a unique study code (PIN) and all information collected for app development will be linked to that number, not to any other identifier. All documents that include identifiers will be stored in a locked, secure location that only key authorized study personnel (e.g. PI, research team members) will have access to.
The interviews will be audio recorded. The recordings will be given an Identification (ID) number and kept in locked cabinets and on secure computers. The audio recordings will be transcribed and kept on password protected computers. (There will be no personal identifiers (such as names) in the transcribed documents.) After the recordings are transcribed, the audio files will be erased.
Only the people listed on the Authorized Research Personnel list will have access to the data. All paper data will be kept in locked files and rooms. Electronic data will be kept in on password- encrypted computers and files with identifying information will be individually password protected. Names and contact information will be stored only for the purpose of contacting participants. This information will be stored separately from study data and the two will only be linked by a study ID, kept in a password protected document. Upon completion of data collection all name and contact information as will be destroyed by file deletion. All data collected for this study will be kept in a locked, secure location and anything that can be destroyed (deleted, shredded, etc.) after it has been coded, will be.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Standard of Care | Active comparator | Other: Group 1: Standard of CareParents of infants born from date July 2020-December 2020 |
| Group 2: NICU2HOME+ app | Active comparator | Other: Group 2: NICU2HOME+ appParents of infants born from mid Jan 2021-May2021 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
- Infants born prematurely with a gestational age of <35 weeks
- Minimum stay in NICU of 7 days
- Competent in English or Spanish (i.e. to fully understand the questions asked in the surveys)
- Smartphone owner
Key exclusion criteria (2 listed)
- Non-adults unable to consent/Cognitively Impaired
- Prisoners or other detained individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1: Standard of CareThose 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 1: Standard of Care |
| Group 2: NICU2HOME+ appIn 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. | Other | Group 2: NICU2HOME+ app |
Primary outcome
Mobile Application Outcome 1
Time frame: 2-3 months
The primary outcome measure understand how the smartphone application improves patient/parent experiences in the NICU. This will be measured through a survey.
Mobile Application Outcome 2
Time frame: 2-3 months
The primary outcome measure will addressing the association of the smartphone application with parenting self-efficacy to improve infants' and parents' health outcomes. This will be measured through a survey.
13 secondary outcomes
State-Trait Anxiety Inventory (STAI)
Time frame: 2-3 months
Parenting Sense of Competence Scale (PSOC)
Time frame: 2-3 months
Edinburgh Postnatal Depression Scale (EPDS)
Time frame: 2-3 months
Press Ganey Questionnaire (PG)
Time frame: 2-3 months
Healthcare encounters (HE)
Time frame: 2-3 months
Readmission rate (RR)
Time frame: 2-3 months
User Version of the Mobile Application Rating Scale (uMARS)
Time frame: 2-3 months
Perinatal PTSD Questionnaire - Modified (PPQ-M)
Time frame: 2-3 months
Coronavirus disease 2019 (COVID-19) Impact Scale
Time frame: 2-3 months
Perceived Stress Scale (PSS)
Time frame: 2-3 months
MOS- Social Support Scale (MOS)
Time frame: 2-3 months
Health Behavior (HB)
Time frame: 2-3 months
Centers for Disease Control (CDC) - Hear Her Campaign
Time frame: 2-3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Background: PubMed 20669423Institute of Medicine (US) Committee on Understanding Premature Birth and Assuring Healthy Outcomes; Behrman RE, Butler AS, editors. Preterm Birth: Causes, Consequences, and Prevention. Washington (DC): National Academies Press (US); 2007. Available from http://www.ncbi.nlm.nih.gov/books/NBK11362/
- Background: PubMed 24927295Garfield CF, Lee Y, Kim HN. Paternal and maternal concerns for their very low-birth-weight infants transitioning from the NICU to home. J Perinat Neonatal Nurs. 2014 Oct-Dec;28(4):305-12. doi: 10.1097/JPN.0000000000000021.
- Background: PubMed 23397099Braveman P. What is health equity: and how does a life-course approach take us further toward it? Matern Child Health J. 2014 Feb;18(2):366-72. doi: 10.1007/s10995-013-1226-9.
- Background: PubMed 20709259Blumenshine P, Egerter S, Barclay CJ, Cubbin C, Braveman PA. Socioeconomic disparities in adverse birth outcomes: a systematic review. Am J Prev Med. 2010 Sep;39(3):263-72. doi: 10.1016/j.amepre.2010.05.012.
- Background: PubMed 21798400MacDorman MF. Race and ethnic disparities in fetal mortality, preterm birth, and infant mortality in the United States: an overview. Semin Perinatol. 2011 Aug;35(4):200-8. doi: 10.1053/j.semperi.2011.02.017.
- BackgroundPew Research Center: Internet Science & Technology. Mobile technology fact sheet. 2018; http://www.pewinternet.org/fact-sheet/mobile/. Accessed January 14, 2019, 2015.
- Background: PubMed 29914860Anderson-Lewis C, Darville G, Mercado RE, Howell S, Di Maggio S. mHealth Technology Use and Implications in Historically Underserved and Minority Populations in the United States: Systematic Literature Review. JMIR Mhealth Uhealth. 2018 Jun 18;6(6):e128. doi: 10.2196/mhealth.8383.
- Background: PubMed 21853160Anoshiravani A, Gaskin G, Kopetsky E, Sandborg C, Longhurst CA. Implementing an Interoperable Personal Health Record in Pediatrics: Lessons Learned at an Academic Children's Hospital. J Particip Med. 2011 Jul 10;3:e30.
- Background: PubMed 18034178Cooper LG, Gooding JS, Gallagher J, Sternesky L, Ledsky R, Berns SD. Impact of a family-centered care initiative on NICU care, staff and families. J Perinatol. 2007 Dec;27 Suppl 2:S32-7. doi: 10.1038/sj.jp.7211840.
- Background: PubMed 19321288De Rouck S, Leys M. Information needs of parents of children admitted to a neonatal intensive care unit: a review of the literature (1990-2008). Patient Educ Couns. 2009 Aug;76(2):159-73. doi: 10.1016/j.pec.2009.01.014. Epub 2009 Mar 24.
- Background: PubMed 10390288Escobar GJ, Joffe S, Gardner MN, Armstrong MA, Folck BF, Carpenter DM. Rehospitalization in the first two weeks after discharge from the neonatal intensive care unit. Pediatrics. 1999 Jul;104(1):e2. doi: 10.1542/peds.104.1.e2.
- Background: PubMed 27990350Garfield CF, Lee YS, Kim HN, Rutsohn J, Kahn JY, Mustanski B, Mohr DC. Supporting Parents of Premature Infants Transitioning from the NICU to Home: A Pilot Randomized Control Trial of a Smartphone Application. Internet Interv. 2016 May;4(Pt 2):131-137. doi: 10.1016/j.invent.2016.05.004. Epub 2016 Jun 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Santiago, MA study director
Northwestern University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 2: NICU2HOME+ app in people with Premature Birth and NICU, run by Northwestern University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobile Application Outcome 1 (time frame: 2-3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04480255, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.