Actively Recruiting

All Genders
ID06057974

Effects of the Close Collaboration With Parents Intervention on Parents of Newborns in the NICU

Led by Nagano Children's Hospital · Updated on 2026-04-13

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research evaluates the effects of the Close Collaboration with Parents, a family-centered care approach for neonatal intensive care unit (NICU) staff, on parents of newborns in the NICU. The study compares experiences before and after this intervention, focusing on family-centered care quality as rated by parents, parental anxiety symptoms, and readiness for the infant's discharge. The intervention is planned to be implemented from December 2023 through December 2024. The Close Collaboration with Parents intervention educates NICU healthcare staff to better observe infants' individual needs, support parents in understanding and participating in their infant's care, and involve parents in decision-making from early care through discharge preparation. Data will be collected during three phases: before the intervention (September to December 2023), during the intervention (January to December 2024), and after (January to April 2025). Parents and newborns admitted before and after the intervention form two groups for comparison. Participants will be parents of infants admitted to the NICU for at least two weeks. Researchers will collect data on family-centered care quality, parental anxiety, and discharge readiness around the infant's discharge at about one month of age. Data will be pseudonymized and securely managed, with statistical analyses adjusting for factors like length of stay and parental mental health history. Participation spans from pre-intervention data collection through post-intervention follow-up, lasting over a year.

CONDITIONS

Brief Title

Close Collaboration and Discharge Readiness

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants who have been admitted to the NICU for 2 weeks or longer
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Participants are identified based on their admission to the NICU and length of stay.

Monitoring

Duration - Approximately 2 weeks or longer depending on NICU stay

Participants and their parents are observed during their admission to the NICU before the intervention is implemented.

Ongoing observations during NICU stay

Monitoring

Duration - Up to about 1 month of age until discharge

Participants and their parents are observed during their admission to the NICU after the intervention is implemented, focusing on family-centered care practices.

Observation and assessments conducted until discharge

Trial Site Locations

Total: 1 location

1

Nagano Children's Hospita

Azumino, Nagano, Japan, 39982822

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Research Team

R

Ryo Itoshima, MD

A

Arata Oda, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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