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Recruiting Observational

Close Collaboration and Discharge Readiness

NCT06057974 · tracked via the Priya Life Science Japan tracker
Sponsor
Nagano Children's Hospital
Phase
Observational
Started
2023-09-28
Last updated
2026-04-13

Condition(s) studied

Family Centered Care

Investigational drug(s) / intervention(s)

Close Collaboration with Parents

Close Collaboration with Parents: The Close Collaboration with Parents intervention is an educational model for healthcare staff working in NICUs. It aims to improve the ability of the members of the NICU healthcare team to I) observe the infants' individual behaviors and needs, II) support parents to take the initiative and share their observations and understanding of their infant's behaviors and to collaboratively plan the infant's care with the healthcare staff, III) understand the individual story of the family regarding parenthood through a dialogue with parents, and IV) involve parents in the decision-making about the care of their baby from an early stage of care through to the preparation for discharge. The final goal is to improve the care culture in the NICUs by changing the attitudes of the healthcare staff and the care practices of the unit to be more in line with family-centered care principles. It usually takes 1.5 years for each NICU to complete the intervention.

Study summary

This prospective non-randomized controlled before-after comparison study aims to evaluate the effects of the Close Collaboration with Parents, a family-centered care intervention for NICU staff, on parents of the newborns in the neonatal intensive care unit (NICU). We focus on (1) family centered care of the NICU rated by parents, (2) parental anxiety symptoms, and (3) their discharge readiness.

The intervention is planned to be implemented between December 2023 and December 2024.

The investigators will collect data from parents whose newborns are admitted to the NICU before and after the intervention and compare the two groups. In most cases, the parents of the two groups belong to different cohorts.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Quality of family centered care rated by parents — at discharge (about 1 month of age)
    The family centered care provided by the medical professionals in the NICU is assessed by parents using a questionnaire modified from DigiFCC questions. It consists of 9 questions. Each question has the Likert scale from 1 to 7 (1 not at all and 7 very much; 0 not applicable). A higher score indicates better family centered care received by parents. The average score of all questions will be used. This is rated by both parents separately.

Trial sites (1)

FacilityCityRegionStatus
Nagano Children's Hospita Azumino Nagano Recruiting

More Nagano Children's Hospital trials in Japan

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06057974 on ClinicalTrials.gov ↗ ← All trials in Japan