Improving pain assessment in preterm infants using machine learning
Rebooting Infant Pain Assessment: Using Machine Learning to Exponentially Improve Neonatal Intensive Care Unit Practice
This study is testing a new way to use machine learning to better understand and measure pain in preterm infants in the NICU during routine procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 27 Weeks to 33 Weeks |
| Sex | All |
| Sponsor | York University Academic / other |
| Locations | 2 sites (Toronto, Ontario and 1 other locations) |
| Trial ID | NCT05579496 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a machine learning algorithm to better assess pain in preterm infants in the Neonatal Intensive Care Unit (NICU). A multinational team will analyze data from 400 preterm infants during routine painful procedures, such as heel lances, to identify distress signals through behavioral and physiological indicators. The goal is to differentiate between pain-related and non-pain-related distress, ultimately enhancing pain management practices in the NICU.
Who should consider this trial
Good fit: Ideal candidates include preterm infants born between 28 to 32 weeks gestational age who are undergoing routine heel lances.
Not a fit: Patients with congenital malformations or those receiving analgesics or sedatives at the time of the study may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate pain assessments and improved pain management for preterm infants.
How similar studies have performed: Other studies utilizing machine learning for pain assessment in infants have shown promise, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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, SPo2) * Inclusion Criteria: * Infants born between 28 0/7 weeks 32 6/7 weeks gestational age * Infants who are within 6 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
Where this trial is running
Toronto, Ontario and 1 other locations
- Mount Sinai Hospital — Toronto, Ontario, Canada (Recruiting)
- University College London Hospital — London, No Province, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Rebecca Pillai Riddell, PhD — York University/Mount Sinai Hospital
- Study coordinator: Rebecca Pillai Riddell, PhD
- Email: rpr@yorku.ca
- Phone: 416736200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.