Early Skin-to-skin ContactNCT05655104
Effects of the Couplet Care in Neonatal Intensive Care Unit
An observational study of Early Skin-to-skin Contact and Psychological Distress, run by Turku University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Early Skin-to-skin Contact, Psychological Distress, Parenting
- What is being tested?
- Couplet Care
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Dec 2023
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Couplet Care on Parents and Parent-infant Dyad in Neonatal Intensive Care Unit: Before and After Comparison Study
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.
Read the 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.
- Being tested
- Couplet Care
- Keywords
- NICU, Family centered care, Couplet care, Parent-infant closeness, Postpartum depression
- Medical subject headings
- Premature Birth, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couplet CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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." Receives: Other: Couplet Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from the birth to the first skin-to-skin contact
The time difference (minutes) between the birth to the first skin-to-skin contact. It will be assessed for each parent. The information will be collected from parents using the questionnaire or from the medical record.
Measured: at 0 day of age
Time from the birth to the first holding
The time difference (minutes) between the birth to the first holding. It will be assessed for each parent. The information will be collected from parents using the questionnaire or from the medical record.
Measured: at 0 day of age
Average daily duration of parents' presence in the hospital room
The duration of parents' presence in the hospital room is measured for 14 days after the consent. The average time will be calculated for each parent (hours per day). The presence is recorded using the Parent-Infant Closeness Diary. This diary is a paper format and has one day per page including three items for each parent: presence, skin-to-skin contact, and holding. Mother and father respectively draw a line on the diary for these items. The start and the end times can be marked with a 5-minute accuracy. The validity of Parent-Infant Closeness Diary has already been evaluated. Parental presence is defined as being in the infant's room in the neonatal intensive care unit.
Measured: at 2 weeks of age
Average duration of skin-to-skin contact
The duration of skin-to-skin contact is measured for 14 days after the consent. The average time per day will be calculated for each parent (minutes per day). The time of skin-to-skin contact is recorded using the Parent-Infant Closeness Diary. This diary is a paper format and has one day per page including three items for each parent: presence, skin-to-skin contact, and holding. Mother and father respectively draw a line on the diary for these items. The start and the end times can be marked with a 5-minute accuracy. The validity of Parent-Infant Closeness Diary has already been evaluated. Skin-to-skin contact is defined as the infant being held by the parent on the bare chest, with only a diaper and a cap if necessary.
Measured: at 2 weeks of age
Average duration of holding
The duration of holding is measured for 14 days after the consent. The average time per day will be calculated for each parent (minutes per day). The time of skin-to-skin contact is recorded using the Parent-Infant Closeness Diary. This diary is a paper format and has one day per page including three items for each parent: presence, skin-to-skin contact, and holding. Mother and father respectively draw a line on the diary for these items. The start and the end times can be marked with a 5-minute accuracy. The validity of Parent-Infant Closeness Diary has already been evaluated. Holding is defined as parent holding the infant who has clothes on.
Measured: at 2 weeks of age
Secondary outcomes (6)
Parental postpartum depressive symptoms
Parental postpartum depressive symptoms will be assessed using Edinburgh Postnatal depression scale (EPDS). It is a self-report questionnaire and comprises 10 items, each of which is scored on a four-point scale (0-3). The total score varies from a minimum of 0 to a maximum of 30, and higher scores indicating more depressive symptoms. The EPDS is analyzed as a continuous variable and also as a proportion of parents exceeding the cutoff score. The cutoff score of clinical depression is 13 or more for mothers and 10 or more for fathers.
Measured: at 2 weeks of age, at discharge (about 2 months of age), and at 4 months of corrected age
Parental anxiety symptoms
Parental anxiety symptoms will be assessed using STAI. The STAI questionnaire assesses two different anxiety types at the same time. State anxiety is an emotional response that can change over time according to the situation. Trait anxiety indicates a personal emotional characteristic that a person has. There are 20 questions for each state and trait anxiety and each is scored on a four-point scale (1-4). The total score in each type of anxiety varies from a minimum of 20 to a maximum of 80, and higher scores indicating more anxiety symptoms. The cutoff score of state anxiety usually used for a postpartum period is 40 or more: those who have a total state-STAI score of 40 or more have higher postpartum anxiety symptoms.
Measured: at discharge (about 2 months of age)
Parent-infant bonding
The feelings of bonding felt by parent towards the newborn are assessed using the Japanese version of Mother-to-Infant Bonding Scale (MIBS-J). MIBS-J is a self-report questionnaire and comprises ten items, each of which is scored on a four-point scale (0-3). The total score varies from 0 to 30, and higher scores indicating a weaker bonding between a mother and her infant.
Measured: at discharge (about 2 months of age)
Quality of family centered care as reported by parents
The family centered care provided by the medical professionals in the NICU is assessed by parents using a questionnaire modified from DigiFCC questions. It consists of 9 questions. Each question has the Likert scale from 1 to 7 (1 not at all and 7 very much; 0 not applicable). A higher score indicates better family centered care received by parents. The average score of all questions will be used.
For families in the pre-intervention cohort, investigators used the same questions but they were delivered daily: parents received one out of the 9 questions as a text message in a random order every evening and responded by a score using their mobile phone.
Measured: at discharge (about 2 months of age)
Breastmilk feeding
Parents are asked a question about breastmilk feeding status: whether the infant is on only breast milk, partially on breast milk, or not on breast milk.
Measured: at discharge (about 2 months of age) and at 4 months of corrected age
Breastfeeding
Parents are asked a question about the breastfeeding status: whether the infant is fed from the breast, bottle, feeding tube, or by any other method.
Measured: at discharge (about 2 months of age) and at 4 months of corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study startJan 2023 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Skin-to-skin ContactStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Liisa Lehtonen, Turku University Hospital
- Investigators
- Liisa Lehtonen, MD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655104
- Sponsor's protocol ID
- CoupletCareStudy/2022
- Status last verified
- Dec 2022
- First submitted
- 30 Nov 2022
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not have a plan to make the data open in the future. However, it can be shared with another personnel or research team for another scientific purposes with the permission of the principal investigator and any other necessary procedures.