Effect of Parents' Presence in Nagano Children's Hospital NICU on Infant and Parent Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The Edinburgh Postnatal Depression Scale (EPDS) of mother 3
研究概览
简要总结
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).
详细描述
<Ethical considerations> This research protocol was approved by the Ethics Committee of Nagano Children's Hospital before this research is being conducted. Recruitment is undertaken by the neonatologists in the unit. They provide written and oral information about the study when they explain infants' condition to their parents at admission. The parents are given sufficient time to consider their participation. The informed consent will be asked within 7 days from the birth, otherwise the infant will be excluded from this study. At least one of the parents should sign the informed consent before enrolment. At the time of agreement, investigators give the infant an anonymous number to protect personal information.
< Power calculation > The sample size should be decided by the number of parents as the primary outcomes are for parents. Investigators plan to include 110 couples or families; the power calculation showed that investigators could detect a 2.5 difference in the mean Edinburgh Postnatal Depression Scale (EPDS) score of longer and shorter presence groups (with power 0.8 and alfa 0.05) with this number of parents.
<Measures and data collection> Diary record Parents make a record on daily diary from the next day of agreement to one day before discharge. Parents make a record about duration of these four topics; presence, skin-to-skin contact (SCC), participation in infant care, and any other interaction with their infants.
- "Care taking" includes the followings; breast feeding, bottle feeding, milking, tube feeding, changing diaper, wiping body, bathing, and any other essential care for baby. However, any care taking during "SCC" mustn't included in this section.
- "Other interaction with baby" includes the followings; hugging, holding, touching, watching, talking, reading books, playing, making something or writing diary for baby, and any other approaches for baby. However, any interaction given during "SCC" or "care taking" mustn't included in this section.
Investigators use the modified Parent-Infant Closeness Diary. The original diary includes three items for each mother and father; presence, holding and SCC. Investigators have changed these items into our own settings as above and changed the used language into Japanese. Investigators already have got the permission from the developers of this diary. This diary has one day per page including all the four topics for both parents. Mother and father respectively draw a line on the blank of specific items they do. They should fill all the corresponding blanks when they do things for multiple babies. The start and the end times should be put in 5-minute increments. The validity of Parent-Infant Closeness Diary has already been proven.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born at 34 weeks of gestation or earlier in Nagano Children's Hospital and need admission into NICU in the same hospital
排除标准
- •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
结局指标
主要结局
The Edinburgh Postnatal Depression Scale (EPDS) of mother 3
时间窗: At discharge of the infant, an average of 2 months postpartum.
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.
Japanese version of Mother-to-Infant Bonding Scale (MIBS-J) for father 1
时间窗: Within 1 month postpartum.
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.
Japanese version of Mother-to-Infant Bonding Scale (MIBS-J) for father 2
时间窗: At discharge of the infant, an average of 2 months postpartum.
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.
The Edinburgh Postnatal Depression Scale (EPDS) of mother 1
时间窗: 2 weeks postpartum.
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.
The Edinburgh Postnatal Depression Scale (EPDS) of father 1
时间窗: Within 1 month postpartum.
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.
The Edinburgh Postnatal Depression Scale (EPDS) of mother 2
时间窗: 4 weeks postpartum.
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.
Japanese version of Mother-to-Infant Bonding Scale (MIBS-J) for mother 1
时间窗: 2 weeks postpartum.
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.
Japanese version of Mother-to-Infant Bonding Scale (MIBS-J) for mother 2
时间窗: 4 weeks postpartum.
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.
Japanese version of Mother-to-Infant Bonding Scale (MIBS-J) for mother 3
时间窗: At discharge of the infant, an average of 2 months postpartum.
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.
The Edinburgh Postnatal Depression Scale (EPDS) of father 2
时间窗: At discharge of the infant, an average of 2 months postpartum.
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.
次要结局
- Frequency of breastfeeding directly from breast at 36 weeks(36 weeks of postmenstrual age.)
- Weight at 36 weeks(36 weeks of postmenstrual age.)
- Height 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.)
- Growth rate of head circumference from birth to discharge home (change)(At birth and discharge, an average of 2 months postpartum.)
- Length of stay(At discharge of the infant, an average of 2 months postpartum.)
- Head circumference at 36 weeks(36 weeks of postmenstrual age.)
- Growth rate of height from birth to discharge home (change)(At birth and discharge, an average of 2 months postpartum.)
- Breastmilk-feeding at discharge(At discharge, an average of 2 months postpartum.)
- Breastmilk-feeding at 36 weeks(36 weeks of postmenstrual age.)
- Frequency of breastfeeding directly from breast at discharge(At discharge, an average of 2 months postpartum.)
- Developmental quotient (DQ) at 18 months of corrected age(At 18 months of corrected age.)
- Developmental quotient (DQ) at 3 years old(3 years old (3 years of postmenstrual age))
- Developmental quotient (DQ) at 6 months of corrected age(At 6 months of corrected age.)