Family Centered Care Cohort Study 1 in Nagano Children's Hospital

NCT04761419 | Active Not Recruiting

• 1 other identifier: FCC-cohort1
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

An observational cohort study to show the effect of parents' presence beside their infants, skin-to-skin contact (SCC), participation in infant care, or any interaction with their infants on parents' and infants' short- and long-term outcomes. Investigators create a hypothesis that longer parents' presence, SCC, participation in infant care, and any interaction with their infants affect outcomes of infants and parents by preventing parents' depression and promoting parent-infant bonding and, in addition, by shortening the length of stay, promoting growth, promoting establishment breastfeeding, and improving developmental outcomes. Parents are asked to make a record of the length of their presence, SCC, participation in infant care, and any interaction with their infants, which are quantitative measurements of family centered care (FCC). Investigators also collect the data related to the background information of the family, delivery, the clinical course of infants, and the outcome measures of the infants and parents. No intervention is included in this research. The study setting is a level IV neonatal intensive care unit (NICU) at Nagano Children's Hospital in Nagano, Japan. Eligible infants are those who are born at 34 weeks of gestation or earlier from Japanese parents in Nagano Children's Hospital and need admission into NICU in the same hospital. Infants are excluded from this study if they have any major anomalies including suspicion of chromosomal disorder on admission, if at least one parent is Not Japanese, or if they do not survive until discharge home. The primary outcomes are the EPDS and Japanese version of Mother-to-Infant Bonding Scale (MIBS-J) of the parents. The secondary outcomes are the followings; (1) length of stay (days), (2) physical measurements at 36 weeks (g or cm) and growth rate from birth to discharge home (g or cm /d), (3) breastmilk-feeding (exclusive, partial, or no breast milk) and the frequency of breastfeeding directly from breast at 36 weeks PMA and at discharge (average frequency per day), and for the infants whose birth weight \<1500g only, (4) developmental quotient (DQ) at 6 and 18 months of corrected age, and 3 years old assessed by Kyoto Scale of Psychological Development (KSPD).

Conditions

Family Centered Care

Outcome Measures

Primary Outcomes (10)

• The Edinburgh Postnatal Depression Scale (EPDS) of mother 1

  Indicators to estimate depression in parents. The total score varies from minimum 0 to maximum 30, and higher scores indicates to have more depressive symptoms.

  2 weeks postpartum.

• The Edinburgh Postnatal Depression Scale (EPDS) of mother 2

  Indicators to estimate depression in parents. The total score varies from minimum 0 to maximum 30, and higher scores indicates to have more depressive symptoms.

  4 weeks postpartum.

• The Edinburgh Postnatal Depression Scale (EPDS) of mother 3

  Indicators to estimate depression in parents. The total score varies from minimum 0 to maximum 30, and higher scores indicates to have more depressive symptoms.

  At discharge of the infant, an average of 2 months postpartum.

• The Edinburgh Postnatal Depression Scale (EPDS) of father 1

  Indicators to estimate depression in parents. The total score varies from minimum 0 to maximum 30, and higher scores indicates to have more depressive symptoms.

  Within 1 month postpartum.

• The Edinburgh Postnatal Depression Scale (EPDS) of father 2

  Indicators to estimate depression in parents. The total score varies from minimum 0 to maximum 30, and higher scores indicates to have more depressive symptoms.

  At discharge of the infant, an average of 2 months postpartum.

• Japanese version of Mother-to-Infant Bonding Scale (MIBS-J) for mother 1

  Indicators to estimate bonding between infant and parents. The total score varies from minimum 0 to maximum 30, and higher scores indicate a problematic bonding between a mother and her infant.

  2 weeks postpartum.

• Japanese version of Mother-to-Infant Bonding Scale (MIBS-J) for mother 2

  Indicators to estimate bonding between infant and parents. The total score varies from minimum 0 to maximum 30, and higher scores indicate a problematic bonding between a mother and her infant.

  4 weeks postpartum.

• Japanese version of Mother-to-Infant Bonding Scale (MIBS-J) for mother 3

  Indicators to estimate bonding between infant and parents. The total score varies from minimum 0 to maximum 30, and higher scores indicate a problematic bonding between a mother and her infant.

  At discharge of the infant, an average of 2 months postpartum.

• Japanese version of Mother-to-Infant Bonding Scale (MIBS-J) for father 1

  Indicators to estimate bonding between infant and parents. The total score varies from minimum 0 to maximum 30, and higher scores indicate a problematic bonding between a mother and her infant.

  Within 1 month postpartum.

• Japanese version of Mother-to-Infant Bonding Scale (MIBS-J) for father 2

  Indicators to estimate bonding between infant and parents. The total score varies from minimum 0 to maximum 30, and higher scores indicate a problematic bonding between a mother and her infant.

  At discharge of the infant, an average of 2 months postpartum.

Secondary Outcomes (14)

• Length of stay

  At discharge of the infant, an average of 2 months postpartum.

• Weight at 36 weeks

  36 weeks of postmenstrual age.

• Height at 36 weeks

  36 weeks of postmenstrual age.

• Head circumference at 36 weeks

  36 weeks of postmenstrual age.

• Growth rate of weight from birth to discharge home (change)

  At birth and discharge, an average of 2 months postpartum.

Interventions

Parents' longer presence beside their infant BEHAVIORAL

They are not intervention. We will collect data about these items.

Also known as: Parents' longer skin-to-skin contact, Parents' longer participation in infant care, Parents' longer interaction with their infant

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

A level IV NICU in Japan

You may qualify if:

• Born at 34 weeks of gestation or earlier in Nagano Children's Hospital and need admission into NICU in the same hospital

You may not qualify if:

• Having any major anomalies including suspicion of chromosomal disorder on admission
• At least one parent is Not Japanese
• The consent is not obtained by day 7
• Do not survive until discharge home

Sponsors & Collaborators

• Nagano Children's Hospital: lead

Study Sites (1)

Nagano Children's Hospital

Azumino, Nagano, 399-8288, Japan

Location

MeSH Terms

Interventions

Infant Care

Intervention Hierarchy (Ancestors)

Child Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ryo Itoshima, MD

  Nagano Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 18, 2021
• Study Start: February 1, 2021
• Primary Completion: March 16, 2024
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)