Clinical trial NCT06057974: Close Collaboration and Discharge Readiness
Official title: Effects of the Close Collaboration with Parents Intervention on Parents of Newborns
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Family Centered Care
Keywords: Staff education
Parental anxiety
Parental discharge readiness
Lead sponsor: Nagano Children's Hospital
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants and their parents who need at least 2 weeks of admission to Nagano Children's Hospital NICU, a level IV NICU in Japan.

Brief 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.

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.

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

Primary outcomes:
measure: Quality of family centered care rated by parents
timeFrame: at discharge (about 1 month of age)
Secondary outcomes:
measure: Parental anxiety symptoms
timeFrame: at discharge (about 1 month of age)
measure: Parental discharge readiness
timeFrame: at discharge (about 1 month of age)
Other outcomes:
Locations:
city: Azumino
country: Japan
facility: Nagano Children's Hospita
state: Nagano
Study officials:
affiliation: Nagano Children's Hospital
name: Ryo Itoshima, MD
role: PRINCIPAL_INVESTIGATOR
References: