NICU DesignNICUDesign/24NCT07877792
NICU Design: Open Space Versus Single Family Room
An observational study of NICU Design, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 2 sites in Italy.
Trial summary
This prospective, multicenter observational study aims to investigate parents' and healthcare professionals' perceptions of neonatal intensive care unit (NICU) design, comparing Open Space and Single Family Room settings. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- NICU Design
- How many people
- 142 participants
- Where
- 2 sitesItaly
- Study dates
- 4 Aug 2025to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population consists of newborns admitted to the Neonatal Intensive Care Units, their parents, and healthcare professionals working in the participating NICUs at Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico in Milan and Ospedale Filippo del Ponte in Varese. The study compares perceptions of the Open Space and Single Family Room NICU settings.
Who may be able to join
- Newborns: gestational age at birth less than 32 weeks or birth weight less than 1500 grams; absence of congenital malformations; absence of grade III or higher intraventricular hemorrhage.
- Parents: age ≥18 years; written informed consent to participate in the study. Participation of either one parent or both parents is allowed.
- Healthcare professionals (physicians, nurses, and pediatric nurses): in service for at least 1 year at the participating Clinical Departments; informed consent to participate in the study.
Who cannot join
- Parents who do not understand Italian, either in written or spoken form.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
Elisa Lagostina, +39 0255032907, elisa.lagostina@policlinico.mi.it
- Not yet recruiting
Ospedale Filippo Del Ponte
Varese, 21100
Maddalena Bassetti, +39 0332 299421, maddalena.bassetti@asstsettelaghi.it
About this study
Official title: Investigation of Parents' and Healthcare Professionals' Perceptions of Neonatal Intensive Care Unit Design: Open Space Versus Single Family Room
This prospective, multicenter observational study aims to investigate parents' and healthcare professionals' perceptions of neonatal intensive care unit (NICU) design, comparing Open Space and Single Family Room settings. Parents' perceived stress and involvement in neonatal care will be assessed using the Parental Stressor Scale-NICU (PSS-NICU) and the Nurse Parent Support Tool (NPST), while healthcare professionals' perceived stress will be assessed using the Stress-Related Vulnerability Scale (SVS). Parents will complete questionnaires at approximately 15 days after admission to the NICU and again approximately 5 days before discharge. Healthcare professionals will complete the questionnaire once during the study.
Read the detailed description
The study investigates parents' and healthcare professionals' perceptions of NICU structure and organization, comparing an Open Space (OS) NICU with a Single Family Room (SFR) NICU.
The primary objective is to assess parents' perceived stress and involvement in the care of their newborn before discharge from the NICU (T2), comparing parents whose newborns are cared for in an Open Space NICU with parents whose newborns are cared for in a Single Family Room NICU.
Secondary objectives include comparing perceptions between mothers and partners, assessing perceived stress among healthcare professionals, evaluating changes in parental stress and involvement between the beginning of the NICU stay (T1) and before discharge (T2), and describing and comparing the demographic and clinical characteristics of parents, healthcare professionals, and newborns in the two NICU settings. The study will also assess parents' opinions and satisfaction regarding the NICU environment and healthcare professionals' opinions regarding NICU design and organization.
This is a prospective, multicenter, national observational study involving two NICUs: the Neonatal Intensive Care Unit of Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico in Milan, which has an Open Space design, and the Neonatal Intensive Care Unit of Ospedale Filippo del Ponte in Varese, which is organized as Single Family Rooms.
Parents will complete the PSS-NICU, NPST, and opinion questionnaires at approximately 15 ± 1 days after admission to the NICU and again at approximately 5 ± 1 days before discharge. Healthcare professionals will complete the SVS and the healthcare professional opinion questionnaire once during the study. Data will be collected through the REDCap electronic platform.
- Conditions
- NICU Design
- Keywords
- Neonatal Intensive Care Unit, NICU Design, Parental stress, Single Family Room
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Open Space | Parents of eligible newborns admitted to the Open Space Neonatal Intensive Care Unit at Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico in Milan. | |
| Single Family Room | Parents of eligible newborns admitted to the Single Family Room Neonatal Intensive Care Unit at Ospedale Filippo Del Ponte in Varese. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental stress measured by the Parental Stressor Scale-NICU (PSS-NICU)
Parental stress will be assessed using the Parental Stressor Scale-NICU (PSS-NICU). Scores will be compared between parents of newborns cared for in the Open Space NICU and parents of newborns cared for in the Single Family Room NICU at T2.
Measured: T2: approximately 5 ± 1 days before discharge from the NICU
Parental involvement in neonatal care measured by the Nurse Parent Support Tool (NPST)
Parental involvement in the care of the newborn will be assessed using the Nurse Parent Support Tool (NPST). Scores will be compared between parents of newborns cared for in the Open Space NICU and parents of newborns cared for in the Single Family Room NICU at T2.
Measured: T2: approximately 5 ± 1 days before discharge from the NICU
Secondary outcomes (12)
Perception of NICU structure and organization in mothers and partners, assessed in terms of stress and involvement
Comparison of stress and involvement scores between mothers and partners of newborns admitted to Open Space versus Single Family Room NICUs at T2.
Measured: T2: approximately 5 ± 1 days before discharge from the NICU
Perceived stress among healthcare professionals measured by the Stress-Related Vulnerability Scale (SVS)
Comparison of perceived stress among healthcare professionals working in Open Space versus Single Family Room NICUs, measured using the Stress-Related Vulnerability Scale (SVS).
Measured: Once, at the end of the morning shift or 12-hour daily shift
Change in parental stress measured by the Parental Stressor Scale-NICU (PSS-NICU) from T1 to T2
Comparison of the change in PSS-NICU scores from T1 to T2 among parents of newborns admitted to Open Space versus Single Family Room NICUs.
Measured: From approximately 15 ± 1 days of NICU stay (T1) to approximately 5 ± 1 days before discharge (T2)
Change in parental involvement in neonatal care measured by the Nurse Parent Support Tool (NPST) from T1 to T2
Comparison of the change in NPST scores from T1 to T2 among parents of newborns admitted to Open Space versus Single Family Room NICUs.
Measured: From approximately 15 ± 1 days of NICU stay (T1) to approximately 5 ± 1 days before discharge (T2)
Healthcare professionals' professional and work characteristics
Comparison of healthcare professionals in Open Space versus Single Family Room NICUs according to educational qualification, professional training, professional experience, weekly working hours, work schedule, and number of patients cared for.
Measured: At study enrollment
Parents' demographic characteristics
Comparison of parents in Open Space versus Single Family Room NICUs according to age, sex, nationality, geographical origin, educational level, employment status, and number of children.
Measured: At study enrollment
Healthcare professionals' demographic characteristics
Comparison of healthcare professionals in Open Space versus Single Family Room NICUs according to age, sex, geographical origin, educational level, professional training, professional experience, and number of children.
Measured: At study enrollment
Gestational age
Comparison of gestational age at birth between newborns admitted to Open Space versus Single Family Room NICUs.
Measured: At birth and approximately 5 ± 1 days before discharge (T2)
Birth weight
Comparison of birth weight between newborns admitted to Open Space versus Single Family Room NICUs.
Measured: At birth and approximately 5 ± 1 days before discharge (T2)
Clinical conditions of newborns
Comparison of the clinical conditions of newborns admitted to Open Space versus Single Family Room NICUs.
Measured: At T1 (15 ± 1 days after birth) and T2 (5 ± 1 days before discharge)
Change in parents' satisfaction with the NICU experience from T1 to T2
Comparison of parents' satisfaction with the NICU experience at the beginning of hospitalization (T1) and before discharge (T2) among parents of newborns admitted to Open Space versus Single Family Room NICUs.
Measured: From T1 (beginning of NICU hospitalization) to T2 (before discharge)
Agreement of healthcare professionals' opinions regarding NICU structure
Assessment of agreement among healthcare professionals regarding NICU furniture, organization of spaces, devices in use, and services.
Measured: Once during the study, at the end of the morning shift or the 12-hour daily shift.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start4 Aug 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NICU DesignStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisa Lagostina, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877792
- Sponsor's protocol ID
- NICUDesign/2024
- Other IDs
- 5837
- Acronym
- NICUDesign/24
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Domanico R, Davis DK, Coleman F, Davis BO Jr. Documenting the NICU design dilemma: parent and staff perceptions of open ward versus single family room units. J Perinatol. 2010 May;30(5):343-51. doi: 10.1038/jp.2009.195. Epub 2010 Jan 14.
PubMed 20072132Tandberg BS, Flacking R, Markestad T, Grundt H, Moen A. Parent psychological wellbeing in a single-family room versus an open bay neonatal intensive care unit. PLoS One. 2019 Nov 5;14(11):e0224488. doi: 10.1371/journal.pone.0224488. eCollection 2019.
PubMed 31689307van Veenendaal NR, van Kempen AAMW, Franck LS, O'Brien K, Limpens J, van der Lee JH, van Goudoever JB, van der Schoor SRD. Hospitalising preterm infants in single family rooms versus open bay units: A systematic review and meta-analysis of impact on parents. EClinicalMedicine. 2020 Jun 6;23:100388. doi: 10.1016/j.eclinm.2020.100388. eCollection 2020 Jun.
PubMed 32548575
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Parents' and Healthcare Professionals' Perceptions of Neonatal Intensive Care Unit Design: Open Space Versus Single Family Room
- ClinicalTrials.gov ID
- NCT07877792
- Acronym / sponsor ID
- NICUDesign/24 / NICUDesign/2024
- Conditions
- NICU Design
- Keywords
- Neonatal Intensive Care Unit, NICU Design, Parental stress, Single Family Room
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 16 Oct 2026 (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.
This prospective, multicenter observational study aims to investigate parents' and healthcare professionals' perceptions of neonatal intensive care unit (NICU) design, comparing Open Space and Single Family Room settings. Parents' perceived stress and involvement in neonatal care will be assessed using the Parental Stressor Scale-NICU (PSS-NICU) and the Nurse Parent Support Tool (NPST), while healthcare professionals' perceived stress will be assessed using the Stress-Related Vulnerability Scale (SVS). Parents will complete questionnaires at approximately 15 days after admission to the NICU and again approximately 5 days before discharge. Healthcare professionals will complete the questionnaire once during the study.
Detailed description
The study investigates parents' and healthcare professionals' perceptions of NICU structure and organization, comparing an Open Space (OS) NICU with a Single Family Room (SFR) NICU.
The primary objective is to assess parents' perceived stress and involvement in the care of their newborn before discharge from the NICU (T2), comparing parents whose newborns are cared for in an Open Space NICU with parents whose newborns are cared for in a Single Family Room NICU.
Secondary objectives include comparing perceptions between mothers and partners, assessing perceived stress among healthcare professionals, evaluating changes in parental stress and involvement between the beginning of the NICU stay (T1) and before discharge (T2), and describing and comparing the demographic and clinical characteristics of parents, healthcare professionals, and newborns in the two NICU settings. The study will also assess parents' opinions and satisfaction regarding the NICU environment and healthcare professionals' opinions regarding NICU design and organization.
This is a prospective, multicenter, national observational study involving two NICUs: the Neonatal Intensive Care Unit of Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico in Milan, which has an Open Space design, and the Neonatal Intensive Care Unit of Ospedale Filippo del Ponte in Varese, which is organized as Single Family Rooms.
Parents will complete the PSS-NICU, NPST, and opinion questionnaires at approximately 15 ± 1 days after admission to the NICU and again at approximately 5 ± 1 days before discharge. Healthcare professionals will complete the SVS and the healthcare professional opinion questionnaire once during the study. Data will be collected through the REDCap electronic platform.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Space | – | –Parents of eligible newborns admitted to the Open Space Neonatal Intensive Care Unit at Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico in Milan. |
| Single Family Room | – | –Parents of eligible newborns admitted to the Single Family Room Neonatal Intensive Care Unit at Ospedale Filippo Del Ponte in Varese. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of newborns admitted to the Neonatal Intensive Care Units, their parents, and healthcare professionals working in the participating NICUs at Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico in Milan and Ospedale Filippo del Ponte in Varese. The study compares perceptions of the Open Space and Single Family Room NICU settings.
Key inclusion criteria (3 listed)
- Newborns: gestational age at birth less than 32 weeks or birth weight less than 1500 grams; absence of congenital malformations; absence of grade III or higher intraventricular hemorrhage.
- Parents: age ≥18 years; written informed consent to participate in the study. Participation of either one parent or both parents is allowed.
- Healthcare professionals (physicians, nurses, and pediatric nurses): in service for at least 1 year at the participating Clinical Departments; informed consent to participate in the study.
Key exclusion criteria (1 listed)
- Parents who do not understand Italian, either in written or spoken form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Parental stress measured by the Parental Stressor Scale-NICU (PSS-NICU)
Time frame: T2: approximately 5 ± 1 days before discharge from the NICU
Parental stress will be assessed using the Parental Stressor Scale-NICU (PSS-NICU). Scores will be compared between parents of newborns cared for in the Open Space NICU and parents of newborns cared for in the Single Family Room NICU at T2.
Parental involvement in neonatal care measured by the Nurse Parent Support Tool (NPST)
Time frame: T2: approximately 5 ± 1 days before discharge from the NICU
Parental involvement in the care of the newborn will be assessed using the Nurse Parent Support Tool (NPST). Scores will be compared between parents of newborns cared for in the Open Space NICU and parents of newborns cared for in the Single Family Room NICU at T2.
12 secondary outcomes
Perception of NICU structure and organization in mothers and partners, assessed in terms of stress and involvement
Time frame: T2: approximately 5 ± 1 days before discharge from the NICU
Perceived stress among healthcare professionals measured by the Stress-Related Vulnerability Scale (SVS)
Time frame: Once, at the end of the morning shift or 12-hour daily shift
Change in parental stress measured by the Parental Stressor Scale-NICU (PSS-NICU) from T1 to T2
Time frame: From approximately 15 ± 1 days of NICU stay (T1) to approximately 5 ± 1 days before discharge (T2)
Change in parental involvement in neonatal care measured by the Nurse Parent Support Tool (NPST) from T1 to T2
Time frame: From approximately 15 ± 1 days of NICU stay (T1) to approximately 5 ± 1 days before discharge (T2)
Healthcare professionals' professional and work characteristics
Time frame: At study enrollment
Parents' demographic characteristics
Time frame: At study enrollment
Healthcare professionals' demographic characteristics
Time frame: At study enrollment
Gestational age
Time frame: At birth and approximately 5 ± 1 days before discharge (T2)
Birth weight
Time frame: At birth and approximately 5 ± 1 days before discharge (T2)
Clinical conditions of newborns
Time frame: At T1 (15 ± 1 days after birth) and T2 (5 ± 1 days before discharge)
Change in parents' satisfaction with the NICU experience from T1 to T2
Time frame: From T1 (beginning of NICU hospitalization) to T2 (before discharge)
Agreement of healthcare professionals' opinions regarding NICU structure
Time frame: Once during the study, at the end of the morning shift or the 12-hour daily shift.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 20072132Domanico R, Davis DK, Coleman F, Davis BO Jr. Documenting the NICU design dilemma: parent and staff perceptions of open ward versus single family room units. J Perinatol. 2010 May;30(5):343-51. doi: 10.1038/jp.2009.195. Epub 2010 Jan 14.
- Background: PubMed 31689307Tandberg BS, Flacking R, Markestad T, Grundt H, Moen A. Parent psychological wellbeing in a single-family room versus an open bay neonatal intensive care unit. PLoS One. 2019 Nov 5;14(11):e0224488. doi: 10.1371/journal.pone.0224488. eCollection 2019.
- Background: PubMed 32548575van Veenendaal NR, van Kempen AAMW, Franck LS, O'Brien K, Limpens J, van der Lee JH, van Goudoever JB, van der Schoor SRD. Hospitalising preterm infants in single family rooms versus open bay units: A systematic review and meta-analysis of impact on parents. EClinicalMedicine. 2020 Jun 6;23:100388. doi: 10.1016/j.eclinm.2020.100388. eCollection 2020 Jun.
- 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.
Elisa Lagostina principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NICU Design, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 2 sites in Italy.
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisa Lagostina (+39 0255032907, elisa.lagostina@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental stress measured by the Parental Stressor Scale-NICU (PSS-NICU) (time frame: T2: approximately 5 ± 1 days before discharge from the NICU). 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 NCT07877792, which also lists 3 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 16 Oct 2026.