Effects of Close Collaboration With Parents Intervention on NICU Care Environments and Long-term Development of Preterm Infants: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Auditory environment: parent and adult speech
研究概览
简要总结
Close Collaboration with Parents intervention is an evidence-based educational intervention for the entire multi-professional staff of neonatal intensive care units (NICUs). The goal of the intervention is to strengthen partnership between staff and parents, enhance parental participation in infant care. There are no studies yet about the effects of the Close Collaboration with Parents intervention on the long-term neurodevelopment and socio-emotional development of very preterm infants and their interaction with their parents. Accordingly, a multicenter cluster randomized controlled trial is planned. Prior to initiating this large-scale study, it is essential to validate the measurement instruments. Therefore, a pilot study will be conducted to assess their feasibility and to determine the appropriate sample size.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Hour 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm infants born below 32 weeks of gestation and/or weighing < 1500 g who receive long-term follow-up at each study site.
排除标准
- •the infant has any major anomalies
- •the infants are triplets or higher order
- •the infant's condition is critical and the survival is uncertain
- •the parents cannot understand the informed consent form in Korean or in Japanese
结局指标
主要结局
Auditory environment: parent and adult speech
时间窗: Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)
The quantity of adult speech is recorded and analyzed. The quantity of adult speech includes the duration (minutes per hour), number of words (per hour), syllables (per hour), and phonemes (per hour). The recording is done with a commercial recording device. The microphone is placed in the incubator or infant cot. The data analyses are performed using ALICE, an open-source tool to count words, syllables, and phonemes.
Auditory environment: sound level and its variation
时间窗: Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)
The sound level includes sound pressure (dB) and its variation. The main focus of this measurement is to detect a sudden change in the sound pressure caused by alarms and other activities which are a common source of stress in a NICU environment. The recording is done with a sound level detector, a different device from that for speech recording. The microphone is placed in the incubator or infant cot. The data analyses are performed using a one-minute resolution of the recording regarding the average, maximum and minimum and 5 and 95 percentiles of the sound level.
Sensitive care: sleep quality and quantity
时间窗: Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)
The artificial intelligence-based algorithm tool to analyze infant behavior with a camera captured image will be used to classify infant state into six categories: Non-REM (rapid eye movement) sleep, REM (rapid eye movement) sleep, drowsy, quiet awake, active awake, and crying. In addition, caretaking and procedures will be recorded and scored. The diary data is used to get information of the times the infants is not under the camera image like during skin-to-skin contact. The camera is custom-designed with the connection to a local computer. The night-vision camera works well also in a dimmed light environment. The module can be used for both infants in an incubator and in an open bed.
Parents' presence and parent-infant skin-to-skin contact
时间窗: Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)
Parents' presence is defined as their presence beside their infant or at least in the same room with the infant. Parent-infant 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. The duration of parents' presence and parent-infant skin-to-skin contact will be recorded using a modified Parent-Infant Closeness Diary. Parents or staff indicate the specific items by drawing a line. The caretaking includes hands-on care and holding, breastfeeding and bottle feeding of the infant. The start and the end times should be put in 5-minute increments.
Type of enteral feeding
时间窗: Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)
The amount of enteral feeding divided into 4 categories, fresh breast milk, refrigerated/frozen breast milk, donated breast milk, and formula milk will be collected per day. Both the absolute amount of milk and its proportion of the total enteral nutrition will be calculated. We hypothesize that the infants will receive more fresh maternal milk after the intervention.
Body weight
时间窗: every 7 days, from enrollment to the NICU discharge (up to 40 weeks of postmenstrual age), 1 month of corrected age, 6 months of corrected age, 18 months of corrected age, and 36 months
The body weight of the participated infant, and its percentile/Z-score based on the standardized growth curve (Fenton 2025 and National growth curve) will be collected.
次要结局
- Breastfeeding(between 36+0 and 36+6 weeks of postmenstrual age (7 days), and between 7 and 1 day before the day of NICU discharge (7 days))
- Parents' parenting self-efficacy(at 36 weeks of postmenstrual age, at the day of NICU discharge (up to 40 weeks of postmenstrual age), and 1 month of corrected age)
- Length of stay and PMA at discharge(at the day of NICU discharge (up to 40 weeks of postmenstrual age))
- Brain MRI(at the term age, between 37+0 and 41+6 weeks of postmenstrual age)
- Parent-infant interaction: eye movement and behavior tracking(at 6 months of corrected age, for 10 minutes)
- Cry diary(at 6 months of corrected age, for 3 days)
- Infant Behavior Questionnaire-Revised (IBQ-R)(at 6 months of corrected age)
- Early Childhood Behavior Questionnaire (ECBQ)(at 18 months of corrected age)
- Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III)(at 18 months of corrected age and 3 years of age)
- Infant Toddler Social Emotional Assessment (ITSEA)(at 18 months of corrected age and 3 years of age)
研究者
Liisa Lehtonen
Professor
Turku University Hospital