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临床试验/NCT05655104
NCT05655104尚未招募不适用

Effects of Couplet Care on Parents and Parent-infant Dyad in Neonatal Intensive Care Unit: Before and After Comparison Study

Turku University Hospital0 个研究点目标入组 30 人开始时间: 2023年1月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
Average daily duration of parents' presence in the hospital room

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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:

结局指标

主要结局

Average daily duration of parents' presence in the hospital room

时间窗: at 2 weeks of age

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.

Time from the birth to the first holding

时间窗: at 0 day of age

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.

Time from the birth to the first skin-to-skin contact

时间窗: at 0 day of age

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.

Average duration of holding

时间窗: at 2 weeks of age

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.

Average duration of skin-to-skin contact

时间窗: at 2 weeks of age

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.

次要结局

  • Parental postpartum depressive symptoms(at 2 weeks of age, at discharge (about 2 months of age), and at 4 months of corrected age)
  • Parental anxiety symptoms(at discharge (about 2 months of age))
  • Parent-infant bonding(at discharge (about 2 months of age))
  • Breastfeeding(at discharge (about 2 months of age) and at 4 months of corrected age)
  • Quality of family centered care as reported by parents(at discharge (about 2 months of age))
  • Breastmilk feeding(at discharge (about 2 months of age) and at 4 months of corrected age)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Liisa Lehtonen

Professor

Turku University Hospital

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