Rebooting Infant Pain Care: Using Machine Learning and Skin-to-Skin Contact to Exponentially Improve Neonatal Intensive Care Unit Practice
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Acute Pain. Базовые параметры: 25 Weeks — 33 Weeks · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Канада, Великобритания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Первичные конечные точки
- Behavioural Correlate of Distress [Срок оценки: 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)]
- Cortical Correlate of Distress [Срок оценки: For 2 hours surrounding painful procedure (time locked to heel lance; approximately 1 hour before to 1 hour after heel lance)]
- Cardiac Correlates of Distress [Срок оценки: Over 2 hours surrounding painful procedure (time locked to heel lance)]
- Oxygen Saturation Correlate of Distress [Срок оценки: Over 2 hours surrounding painful procedure (time locked to heel lance; approximately 1 hour before to 1 hour after heel lance)]
- Respiration Rate Correlate of Distress [Срок оценки: [Time Frame: Over 2 hours surrounding painful procedure (time locked to heel lance; approximately 1 hour before to 1 hour after heel lance)]]
Вторичные конечные точки (6)
- Birthing Parent Heart Rate and Respiration Rate [Срок оценки: [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: [Срок оценки: Extracted from participants' medical charts following study completion]
- Chart Review of Cumulative Painful Procedures [Срок оценки: Extracted from participants' medical charts following study completion]
- Parent Self-Report Questionnaires [Срок оценки: 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) [Срок оценки: Documented following the study completion]
- Semi-Structured Interview [Срок оценки: 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.]
Критерии участия
QUALITATIVE INTERVIEWS
Критерии включения
- Parents of a child currently in the NICU or
- Health professionals currently working in the NICU.
Критерии исключения
\*Participants who cannot communicate fluently in English
QUANTITITATIVE DATA CAPTURE (video, eeg, ecg, RR, SPo2)
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Канада · 1 центр
- Mount Sinai Hospital — Toronto
Великобритания · 1 центр
- University College London Hospital — London
Идентификаторы
NCT: NCT05579496 · 19-0252-A