Evaluating the Effects of Kangaroo Care in the NICU
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Parent Physiologic Stress
研究概览
简要总结
The main hypothesis of this study is that Kangaroo Father Care (KFC) will positively impact acute physiologic and long-term behavioral outcomes in infants, fathers, and families.
详细描述
Screening:
Participants will be recruited from the NICU at Prentice Women's Hospital. A member of the study team will screen all NICU patients for inclusion and exclusion criteria by reviewing electronic medical records. A screening and enrollment log will be kept to track families who have been approached and agreed or declined to participate in the study. The screening and enrollment log will be kept on a secure REDCap server housed by Northwestern University. Only the study team will have access to this log.
Kangaroo Care (KC) Intervention:
After enrollment, families will be scheduled to participate in two sessions of KC over two sequential days. The goal will be to schedule the KC sessions for the same time of day (i.e. morning, afternoon, or evening). However, if this is not possible given the parents', the sessions will be scheduled for any time of day that participating parents are able to visit their infant in the NICU. Each session will include two hours of continuous KC, with one day focused on Kangaroo Mother Care (KMC) and the other on Kangaroo Father Care (KFC), in a randomized order. These sessions will include continuous skin-to-skin holding of the infant by the parent, per standard of care protocol.
Physiologic Recording:
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
- 1 Day 至 20 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants: Infants who are born at Prentice Women's Hospital between 30 0/7 and 36 6/7 weeks gestation, are ≤20 days old at the time of enrollment, and do not meet any of the study's exclusion criteria will be eligible for participation in this study. Additionally, infants will only be included in this study if both of their biological parents are eligible and agree to participate.
- •Parents: Parents who are ≥18 years of age, English speaking, expect mother and father to raise the infant together in the same household regardless of their marital status, and do not meet any of the study's exclusion criteria will be eligible for participation in this study. Additionally, family units will only be included in this study if both biological parents of the infant are eligible and agree to participate. Only English speaking parents will be included in this trial because the study questionnaires are only available in English.
排除标准
- •Infants: Infants who are intubated or sedated, are receiving vasopressors or analgesics, have any congenital anomalies or skin abnormalities deemed likely to impact KC by clinical team, have received or are planned to receive surgical intervention, or are experiencing other symptoms or receiving other intervention that will impact the utilization of KC, wearable sensors, and/or oral swabs will be excluded from this study.
- •Parents: Parents who are showing any signs of illness or taking corticosteroids or testosterone supplementation will be excluded from this study. Non-English speaking parents will also be excluded from this study because the questionnaires associated with this study are only available in English.
结局指标
主要结局
Parent Physiologic Stress
时间窗: up to 48 hours, during scheduled skin-to-skin participation
Parent physiologic stress will be assessed through heart rate (HR) and HR variability (HRV) data collected before, during, and after KC.
Infant Cardiorespiratory Stability
时间窗: up to 48 hours, during scheduled skin-to-skin participation
Heart rate (HR), oxygen saturation (SpO2), and HR variability (HRV) data collected before, during, and after KC will be combined to report infant cardiorespiratory stability.
次要结局
- Accelerometry Accuracy(up to 48 hours, during scheduled skin-to-skin participation)
- Parent Stress Response(Up to 4 hours. Before, during, and after each study skin-to-skin session)
- Parent Relationship Quality(An average of 6 weeks. Day of study consent, day before discharge, 2 weeks post discharge, 4 weeks post discharge)
- Infant Salivary Biomarker Analysis(Up to 4 hours. Before, during, and after each study skin-to-skin session)
- Paternal Bonding(Up to 4 hours. Before, during, and after each study skin-to-skin session)
- Parent Bonding(An average of 6 weeks. Day of study consent, day before discharge, 2 weeks post discharge, 4 weeks post discharge)
- Parent Sense of Competency(An average of 4 weeks. Day before discharge, 2 weeks post discharge, 4 weeks post discharge)
研究者
Craig Garfield
Professor of Pediatrics and Medical Social Sciences
Ann & Robert H Lurie Children's Hospital of Chicago