An observational study in NICU Design, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Recruiting at 2 sites in Italy. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Observational
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.
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.
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 232 studies on the registry; 83 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
Parents of eligible newborns admitted to the Open Space Neonatal Intensive Care Unit at Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico in Milan.
Parents of eligible newborns admitted to the Single Family Room Neonatal Intensive Care Unit at Ospedale Filippo Del Ponte in Varese.
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.
Time frame: 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.
Time frame: T2: approximately 5 ± 1 days before discharge from the NICU
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.
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)
Comparison of perceived stress among healthcare professionals working in Open Space versus Single Family Room NICUs, measured using 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
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.
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
Comparison of the change in NPST scores from T1 to T2 among parents of newborns admitted to Open Space versus Single Family Room NICUs.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: At study enrollment
Gestational age
Comparison of gestational age at birth between newborns admitted to Open Space versus Single Family Room NICUs.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: Once during the study, at the end of the morning shift or the 12-hour daily shift.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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