Clinical trial Recruiting at 1 site Observational

Improving Family Centered Care in the NICU

Official title: Effects of the Close Collaboration With Parents Intervention on Parents of Newborns

Run by Nagano Children's Hospital · NCT06057974 · Data updated 2026-11-12

This study is testing a new approach to involve parents more in their newborn's care in the NICU to see if it helps reduce their anxiety and makes them feel more ready for discharge.

Quick facts

Study typeObservational
SexAll
Enrollment60 (estimated)
SponsorNagano Children's Hospital
Academic / other
Locations1 site (Azumino, Nagano)
StatusRecruiting
StartedSeptember 28, 2023
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedApril 13, 2026
Trial IDNCT06057974 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are parents of infants who have been admitted to the NICU for two weeks or longer.

Probably not a fit

Parents whose primary language is not Japanese or who require psychiatric consultation after birth may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the impact of a family-centered care intervention called Close Collaboration with Parents on parents of newborns in the neonatal intensive care unit (NICU). The study will collect data from parents before and after the intervention to assess changes in the quality of family-centered care, parental anxiety symptoms, and discharge readiness. The intervention is set to be implemented from January 2024 to December 2024, with data collection occurring in phases around this period. Statistical analyses will be conducted to compare outcomes between the two groups of parents.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce parental anxiety and improve discharge readiness for families with infants in the NICU.

How similar studies have gone: While family-centered care approaches have been explored in other studies, this specific intervention is novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Infants who have been admitted to the NICU for 2 weeks or longer

Exclusion Criteria:

* Infants whose parent doesn't have Japanese as their mother tongue
* Infants whose parent needs psychiatric consultation after birth

Where it's running

  • Nagano Children's Hospita
    Azumino, Nagano, Japan
    Recruiting

Study contacts

  • Principal investigator: Ryo Itoshima, MD — Nagano Children's Hospital
  • Study coordinator: Ryo Itoshima, MD
  • Email: ryitos@utu.fi
  • Phone: +358-29-450-5000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Family-centred care in UK inpatient wards

    This study tests how family involvement in adult internal medicine wards is understood and experienced by patients, their families, and nurses at Milton Keynes University Hospital.

    Recruiting Milton Keynes University Hospital NHS Foundation Trust · Milton Keynes, Buckinghamshire · NCT07740369

  • Family-integrated newborn care for preterm and low-birth-weight babies

    This project will try training and integrating parents into hospital care for preterm and low-birth-weight newborns in Tigray to see if it shortens hospital stays and improves outcomes.

    Recruiting Laerdal Foundation · Mek'ele, Tigray and 1 other locations · NCT07364903

  • Involving families in ICU rounds to improve care engagement

    This study tests if including families in rounds at adult ICUs can help them feel more involved and satisfied with the care their loved ones receive.

    Recruiting at 2 sites Lady Davis Institute · Montreal, Quebec and 1 other locations · NCT06586541

  • Improving family engagement in critical care settings

    This study is testing a new tool to see if it helps families of ICU patients feel more involved and satisfied with their loved one's care.

    Recruiting at 2 sites Lady Davis Institute · Montreal, Quebec and 1 other locations · NCT06586528

  • Assessing outcomes of family-centered care for preterm infants and their parents

    This study is testing if improved family-centered care in the NICU helps preterm babies and their parents feel better and do better as they grow.

    Recruiting University of Giessen · Ulm, Baden-Wurttemberg and 1 other locations · NCT05286983

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.