Improving pain assessment in preterm infants using machine learning
Official title: Rebooting Infant Pain Care: Using Machine Learning and Skin-to-Skin Contact to Exponentially Improve Neonatal Intensive Care Unit Practice
Run by York University · NCT05579496 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 25 Weeks to 33 Weeks |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | York University Academic / other |
| Locations | 2 sites (Toronto, Ontario and 1 other locations) |
| Status | Recruiting |
| Started | November 1, 2020 |
| Main results expected | March 2030 |
| Study ends | March 2031 |
| Registry record updated | July 13, 2026 |
| Trial ID | NCT05579496 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include preterm infants born between 28 to 32 weeks gestational age who are undergoing routine heel lances.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies utilizing machine learning for pain assessment in infants have shown promise, indicating potential for success in this approach.
Who can join: the full rules
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, 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
Where it's running
-
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: 4167362100
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Predictors of severe pain within 24 hours after cesarean delivery with spinal anesthesia
This study will look at which pre-, intra-, and post-operative factors are linked to severe pain in the first 24 hours after an elective cesarean done with spinal anesthesia.
-
Transverse vs Longitudinal Serratus Anterior Plane Block for Breast Surgery
This trial tests whether a longitudinal ultrasound view for serratus anterior plane block provides better pain relief after breast surgery than the standard transverse view.
-
Combined PECS II and PIP blocks vs TPVB for post-mastectomy pain relief
This trial tests whether a combination of PECS II and superficial PIP blocks can provide better or similar pain relief after mastectomy compared with the standard thoracic paravertebral block.
-
Ketamine or Dexmedetomidine as an Additive to Scalp Block for Brain Tumor Surgery
This trial tests whether adding ketamine or dexmedetomidine to bupivacaine for scalp blocks improves pain control after supratentorial brain tumor removal.
-
Rhythmic Skin Tapping and Internal Vibration for Pediatric Venipuncture Pain and Fear
This study tests whether light fingertip tapping above the needle site or a humming sound can reduce pain and fear in children aged 6-12 during blood draws.
-
Brief audio-guided mindfulness for pain in orthopedic waiting rooms
This trial tests whether listening to short mindfulness audio clips can help reduce pain for adults waiting for orthopedic care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.