Open Space vs Single Family Room NICU design and parental stress
Official title: Investigation of Parents' and Healthcare Professionals' Perceptions of Neonatal Intensive Care Unit Design: Open Space Versus Single Family Room
Run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · NCT07877792 · Data updated 2026-11-12
This observational study will compare how Open Space and Single Family Room NICUs affect parental stress and involvement in care, as reported by parents and healthcare professionals.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 142 (estimated) |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 2 sites (Milan and 1 other locations) |
| Status | Recruiting |
| Started | August 4, 2025 |
| Main results expected | September 2027 |
| Study ends | September 2027 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT07877792 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Parents of very preterm or very low birth weight infants cared for in the two participating NICUs, and healthcare professionals working in those units.
✕Probably not a fit
Parents or staff who do not consent or who do not understand Italian will not participate and will not receive any benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multicenter observational study conducted in two NICUs. It compares Open Space and Single Family Room designs and their impact on parental stress, involvement, and satisfaction, as well as healthcare professionals' stress. Parents will complete validated questionnaires at about 15 days after admission and again before discharge; healthcare professionals will complete them once. The study will describe demographic and clinical characteristics and explore differences between mothers and partners, and between the two NICU settings. Inclusion targets include very preterm or very low birth weight infants, with consent from parents and eligible staff.
Why it matters
Potential benefit: Findings could guide NICU design decisions to reduce parental stress and improve family involvement.
How similar studies have gone: Previous work has explored NICU design and family experience, but this multicenter observational comparison provides novel, context-specific insights.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Parents who do not understand Italian, either in written or spoken form.
Where it's running
-
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy Recruiting -
Ospedale Filippo Del Ponte
Varese, Italy Not yet recruiting
Study contacts
- Principal investigator: Elisa Lagostina — Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Study coordinator: Elisa Lagostina
- Email: elisa.lagostina@policlinico.mi.it
- Phone: +39 0255032907
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.