Clinical trial NCT05655104: Effects of the Couplet Care in Neonatal Intensive Care Unit
Official title: Effects of Couplet Care on Parents and Parent-infant Dyad in Neonatal Intensive Care Unit: Before and After Comparison Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Early Skin-to-skin Contact
Psychological Distress
Parenting
Preterm Infant
Keywords: NICU
Family centered care
Couplet care
Parent-infant closeness
Postpartum depression
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2022-12-19
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Families of preterm infants born below 35 weeks of gestation at Turku University Hospital, a level III neonatal intensive care unit in Finland

Brief summary: This is a quasi-experimental before and after intervention study taking place in the level III NICU of Turku University Hospital in Finland to evaluate the effects of the Couplet Care, a care model which provides maternal and infant care in the same room even when intensive care of the infant is needed. The investigators will prospectively collect data after starting Couplet Care. The pre-intervention data was already collected during 2018 and 2019 as a part of the 2nd International Closeness Survey.

Detailed description: Background: It is essential to keep newborn infants and their parents together for the well-being of both. However, the families whose infants need admission to the neonatal intensive care unit (NICU) are often separated. One of the solutions to reduce parent-infant separation is couplet care, where both mother and newborn infant receive their postpartum care in the same hospital room, even if the infant needs intensive care. However, currently only a few NICUs practice couplet care, and the scientific evidence to support implementing couplet care has been scarce. Since moving into the new hospital building in 2022, Turku University Hospital has provided "couplet care model" for all the mother-infant pairs admitted to the neonatal intensive care unit. In addition, all NICU rooms have two adult beds to accommodate both parents.

Aims: The objective of the study is to evaluate the effects of couplet care model on parent and infant well-being. The primary outcome measure is parent-infant closeness, including 1) the time from the birth to the first skin-to-skin contact (SSC) and holding, 2) the duration of parents' presence in the NICU measured for 14 days during the first three weeks, and 3) the duration of SSC and holding measured for 14 days during the first three week after the birth. The secondary outcomes are parental postpartum depressive and anxiety symptoms, parent-infant bonding, the parent-reported quality of family centered care, and breastfeeding success up to the 4 months of corrected age. In addition, factors influencing the realization of early SSC and parents' presence in the NICU are explored by interviews and questionnaires.

Methods: This is a quasi-experimental before and after intervention study taking place in a level III NICU in Turku University Hospital. The pre-intervention data was obtained from 30 families (and 40 infants) during the 2nd International Closeness Survey in 2018 and 2019. The couplet care model has been offered to all families in Turku University Hospital NICU since February 2022. The post-intervention data will be collected prospectively starting in December 2022. The families of preterm infants born before 35 weeks will be eligible for the study. The informed consent must be obtained within 6 days of life. The recruitment will continue until 30 families with a full set of data is recruited.

The duration of parental presence and the duration of SSC in the NICU will be measured using self-reported Parent-Infant Closeness Diary during a 14-day time period after recruitment in the study. Parental postpartum depressive and anxiety symptoms, mother-to-infant bonding and parent-reported quality of family centered care will be assessed by self-report questionnaires (Edinburgh Postnatal Depression Scale, State and Trait Anxiety Inventory, Japanese version of Mother-to-Infant Bonding Scale, and modified DigiFCC, respectively). In addition, parents are asked to fill in a questionnaire about breastfeeding success. The factors influencing the practice of early skin-to-skin contact and parents´ presence in the NICU will be examined by semi-structured qualitive interviews.

Eligibility criteria: \[Family\]

Inclusion Criteria:

* Families of preterm infants born below 35 weeks of gestation at Turku University Hospital

Exclusion Criteria:

* The expected duration of hospitalization is less than 3 days
* Outborn infants
* The infants are triplets or more
* The parents cannot understand the informed consent form in either Finnish, Swedish, English, or Russian
* The infant's condition is critical and survival is uncertain

\[healthcare staff\]

Inclusion Criteria:

* All healthcare staff who have the possibility to participate in the decision about parent-infant early skin-to-skin contact after the delivery.

Exclusion Criteria:

* No

Primary outcomes:
measure: Time from the birth to the first skin-to-skin contact
timeFrame: at 0 day of age
measure: Time from the birth to the first holding
timeFrame: at 0 day of age
measure: Average daily duration of parents' presence in the hospital room
timeFrame: at 2 weeks of age
measure: Average duration of skin-to-skin contact
timeFrame: at 2 weeks of age
measure: Average duration of holding
timeFrame: at 2 weeks of age
Secondary outcomes:
measure: Parental postpartum depressive symptoms
timeFrame: at 2 weeks of age, at discharge (about 2 months of age), and at 4 months of corrected age
measure: Parental anxiety symptoms
timeFrame: at discharge (about 2 months of age)
measure: Parent-infant bonding
timeFrame: at discharge (about 2 months of age)
measure: Quality of family centered care as reported by parents
timeFrame: at discharge (about 2 months of age)
measure: Breastmilk feeding
timeFrame: at discharge (about 2 months of age) and at 4 months of corrected age
measure: Breastfeeding
timeFrame: at discharge (about 2 months of age) and at 4 months of corrected age
Other outcomes:
measure: Qualitative interviews for parents
timeFrame: at 2 weeks of age
measure: Qualitative interviews for healthcare staff in the neonatal intensive care unit
timeFrame: within about a week after the decision of early skin-to-skin contact is made
measure: Questionnaire of Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM)
timeFrame: any time during the study period, within about six months after the start of this study
measure: Emotional Closeness questionnaire
timeFrame: at discharge (about 2 months of age)
Locations:
Study officials:
affiliation: Turku University Hospital
name: Liisa Lehtonen, MD
role: PRINCIPAL_INVESTIGATOR
References: