Effects of the Couplet Care in Neonatal Intensive Care Unit

NCT ID: NCT05655104

Last Updated: 2022-12-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2023-12-31

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.

Conditions

Early Skin-to-skin Contact; Psychological Distress; Parenting; Preterm Infant

Keywords

NICU; Family centered care; Couplet care; Parent-infant closeness; Postpartum depression

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Couplet Care group and their historical controls

Postintervention group: All parents enrolled in 2022-23 are classified into this group. They receive the intervention "Couplet Care."

Pre-intervention group: All parents enrolled in 2018-19 are treated as controls. They did not receive the intervention "Couplet Care."

Couplet Care

Intervention Type: OTHER

In the Couplet Care model, the parents are provided access to the infant stabilisation room and encouragement for early skin-to-skin contact, mothers receive their postpartum care in the same NICU room with the infant, and fathers/partners also have a bed in the same NICU room.

Interventions

Couplet Care

In the Couplet Care model, the parents are provided access to the infant stabilisation room and encouragement for early skin-to-skin contact, mothers receive their postpartum care in the same NICU room with the infant, and fathers/partners also have a bed in the same NICU room.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• 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

• 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]

• No

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Turku University Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Liisa Lehtonen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liisa Lehtonen, MD

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Central Contacts

Liisa Lehtonen, MD

Role: CONTACT

Phone: +358-40-8318322

Email: lianle@utu.fi

Ryo Itoshima, MD

Role: CONTACT

Phone: +358-44-951-5869

Email: ryitos@utu.fi

Other Identifiers

CoupletCareStudy/2022

Identifier Type: -

Identifier Source: org_study_id