Rebooting Infant Pain Care: Using Machine Learning and Skin-to-Skin Contact to Exponentially Impr… (NCT05579496) | Clinical Trial Compass
RecruitingNot Applicable
Rebooting Infant Pain Care: Using Machine Learning and Skin-to-Skin Contact to Exponentially Improve Neonatal Intensive Care Unit Practice
Canada, United Kingdom400 participantsStarted 2020-11-01
Plain-language summary
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.
Who can participate
Age range
25 Weeks – 33 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
QUALITATIVE INTERVIEWS
Inclusion Criteria:
* Parents of a child currently in the NICU or
* Health professionals currently working in the NICU.
Exclusion Criteria:
\*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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Behavioural Correlate of Distress
Timeframe: 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)
2
Cortical Correlate of Distress
Timeframe: For 2 hours surrounding painful procedure (time locked to heel lance; approximately 1 hour before to 1 hour after heel lance)
3
Cardiac Correlates of Distress
Timeframe: Over 2 hours surrounding painful procedure (time locked to heel lance)
4
Oxygen Saturation Correlate of Distress
Timeframe: Over 2 hours surrounding painful procedure (time locked to heel lance; approximately 1 hour before to 1 hour after heel lance)
5
Respiration Rate Correlate of Distress
Timeframe: [Time Frame: Over 2 hours surrounding painful procedure (time locked to heel lance; approximately 1 hour before to 1 hour after heel lance)]