Close Collaboration and Discharge Readiness
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Close Collaboration with Parents.
- Who it may be relevant to
- Registry conditions: Family Centered Care. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of the Close Collaboration With Parents Intervention on Parents of Newborns
Overview
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.
Detailed description
Study period Pre-intervention data collection phase: September 2023 - December 2023 (Planned) Intervention phase: January 2024 - December 2024 (Planned) Post-intervention data collection phase: January 2025 - April 2025 (Planned)
Outcome measures Primary outcome: Quality of family centered care rated by parents Secondary outcomes: Parental anxiety symptoms and parental discharge readiness
Data management Eligible infants and their information will be identified and collected by research team members and entered into the excel file (.xlsx). Data will be pseudonymized when the data is entered into the excel file. All electronic data will be destroyed 10 years after the initiation of the study.
The principal investigator will be responsible for managing access to the data. We do not have a plan to make the data open in the future.
Statistical analysis The comparison between two continuous variables will be carried out by the student t test and, additionally, the multiple linear regression model and the logistic regression model to adjust the effect of the potential confounders. The potential confounders included in the models will be the length of stay and parents' previous mental illness.
R and RStudio will be used to analyze the data.
Interventions
- Other 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 pa
Primary outcome measures
- Quality of family centered care rated by parents [Time frame: at discharge (about 1 month of age)]
Secondary outcome measures (2)
- Parental anxiety symptoms [Time frame: at discharge (about 1 month of age)]
- Parental discharge readiness [Time frame: at discharge (about 1 month of age)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Japan · 1 center
- Nagano Children's Hospita — Azumino
Identifiers
NCT: NCT06057974 · S-05-49