Rebooting Infant Pain Care: Using Machine Learning and Skin-to-Skin Contact to Exponentially Improve Neonatal Intensive Care Unit Practice
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Cortical Correlate of Distress
研究概览
简要总结
To address the current limitations related to infant pain assessment in the NICU, our international team of knowledge users and health/natural science/engineering/social science researchers have come together to build a machine learning algorithm that will learn how to discriminate invasive and non-invasive distress. Furthermore, to improve the use of current pain management practices, our team seeks to better understand the developmental mechanisms underlying skin-to-skin contact over time and factors that may influence its efficacy in mitigating pain responses in preterm infants. This is an ongoing naturalistic observational study.
详细描述
Unmanaged pain in hospitalized infants has serious long-term complications. Existing infant pain assessment approaches demonstrate several key flaws (e.g., dependent on human cognitive capacity to simply combine data from multiple indicators into a total pain score, none have passed a critical discriminant validity test, bias introduced from human caregivers). Thus, the complexity of preterm pain assessment necessitates a machine learning approach. Our international team of knowledge users and health/natural science/engineering/social science researchers have come together to build a machine learning algorithm that will learn how to discriminate invasive and non-invasive distress. Furthermore, better understanding how skin-to-skin contact works in caregiver-infant dyads and factors that influence the effectiveness of this pain management strategy is a critical step in improving infant pain care in NICUs. Relatedly, the design and sample of our current study (acute pain paradigm while infant is either in skin-to-skin contact with the birthing parent or in the cot) allows us to not only test the influence of skin-to-skin contact vs. cot on preterm newborn pain responding, but also interrogate potential mechanisms underlying the effectiveness of skin-to-skin contact (i.e., cardiac regulation attunement between caregivers and their infants during the procedure; influence of birthing parent perceived stress given the particularly elevated stress levels of NICU parents). A sample of 400 preterm infants (300 from Mount Sinai Hospital and 100 from University College London Hospital [UCLH]) and their birthing parents (if available) will be followed during a routine painful procedure (heel lance). Pain indicators (facial grimacing [behavioural indicators], heart rate, respiration rate, oxygen saturation levels [physiologic indicators], brain electrical activity) during the painful procedure will be used to train the algorithm to discriminate between different types of distress (pain-related and non-pain related). Heart rate and respiration rate, as well as maternal-reported perceived stress levels, will be collected from the birthing parent to examine factors impacting the effectiveness of skin-to-skin contact.
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
- 25 Weeks 至 33 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •QUALITATIVE INTERVIEWS
- •Inclusion Criteria:
- •Parents of a child currently in the NICU or
- •Health professionals currently working in the NICU.
排除标准
- •*Participants who cannot communicate fluently in English
- •QUANTITITATIVE DATA CAPTURE (video, eeg, ecg, RR, SPo2)
- •Inclusion Criteria:
- •Infants born between 25 0/7 weeks 32 6/7 weeks gestational age
- •Infants who are within 8 weeks postnatal age
- •Infants who are undergoing a routine heel lance
- •Exclusion Criteria:
- •Infants with congenital malformations
- •Infants receiving analgesics or sedatives at the time of study (aside from sucrose)
- •Infants with history of perinatal hypoxia/ischemia at the time of study
- •Infants with diaper rash or excoriated buttocks
- •Parents who are not fluent in English
研究组 & 干预措施
Infants Hospitalized in the NICU
Infants born between 25 0/7 weeks 32 6/7 weeks gestational age, who are within 8 weeks postnatal age, and their caregiver (if available) and/or health professional will be recruited for qualitative interview. Infants will participate in the study either in skin-to-skin contact with the birthing parent or in the cot if the parent is unable to participate. If the baby participates in a skin-to-skin study, they will be transferred from the cot to skin-to-skin following EEG electrode placement and a 10-minute cot baseline recording. Babies will be then exposed to a sham lance and a real lance while in skin-to-skin. For cot studies, babies are kept in the cot for the whole study duration, and thus the sham lance and real lance will be conducted while they are in the cot receiving standard care.
结局指标
主要结局
Cortical Correlate of Distress
时间窗: For 2 hours surrounding Painful procedure (time locked to heel lance; approximately 1 hour before to 1 hour after heel lance)
To be analyzed using machine learning via bedside monitoring: Continuous EEG data capture
Oxygen Saturation Correlate of Distress
时间窗: Over 2 hours surrounding Painful procedure (time locked to heel lance; approximately 1 hour before to 1 hour after heel lance)
To be analyzed using machine learning via bedside monitoring: amount of oxygen-carrying hemoglobin in the blood relative to the amount of hemoglobin not carrying oxygen
Cardiac Correlates of Distress
时间窗: Over 2 hours surrounding Painful procedure (time locked to heel lance)
To be analyzed using machine learning via bedside monitoring: Heart Rate, Heart Rate Variability
Behavioural Correlate of Distress
时间窗: NFCS-P coded in 1-5 minute epochs, over 2 hour surrounding painful procedure (time locked to heel lance; approximately 1 hour before to 1 hour after heel lance)
To be analyzed using machine learning via bedside videography: Facial Grimacing using Neonatal Facial Coding System (NFCS-P subset; Bucsea et al., 2022, 10.1097/j.pain.0000000000002798)
Cortical Correlate of Distress
时间窗: For 2 hours surrounding painful procedure (time locked to heel lance; approximately 1 hour before to 1 hour after heel lance)
To be analyzed using machine learning via bedside monitoring: Continuous EEG data capture
Cardiac Correlates of Distress
时间窗: Over 2 hours surrounding painful procedure (time locked to heel lance)
To be analyzed using machine learning via bedside monitoring: Heart Rate, Heart Rate Variability
Oxygen Saturation Correlate of Distress
时间窗: Over 2 hours surrounding painful procedure (time locked to heel lance; approximately 1 hour before to 1 hour after heel lance)
To be analyzed using machine learning via bedside monitoring: amount of oxygen-carrying hemoglobin in the blood relative to the amount of hemoglobin not carrying oxygen
Respiration Rate Correlate of Distress
时间窗: [Time Frame: Over 2 hours surrounding painful procedure (time locked to heel lance; approximately 1 hour before to 1 hour after heel lance)]
To be analyzed using machine learning via bedside monitoring: Respiratory patterns
次要结局
- Semi-Structured Interview(These interviews are occurring at the beginning of the study and will be qualitatively analyzed. They are not linked to infants whose data we are collecting primary outcomes.)
- Birthing Parent Heart Rate and Respiration Rate([Time Frame: Over 1.5 hours surrounding painful procedure (time locked to heel lance)])
- Chart review of general health indicators and other NICU experiences (control as potential confounders), such as:(Extracted from participants' medical charts following study completion)
- Chart Review of Cumulative Painful Procedures(Extracted from participants' medical charts following study completion)
- Parent Self-Report Questionnaires(Completed at the beginning of the study while EEG electrodes are being applied to the baby)
- Detailed documentation of noxious and sham stimulation details: (Control for their influence on infant responses)(Documented following the study completion)
研究者
Rebecca Pillai Riddell
Full Professor
York University