Rebooting Infant Pain Care: Using Machine Learning and Skin-to-Skin Contact to Exponentially Improve Neonatal Intensive Care Unit Practice (NCT05579496)
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (9 items).
Location: Mount Sinai Hospital — Toronto, Ontario
Age range: 25 Weeks to 33 Weeks
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (2 Sites)
- Mount Sinai Hospital — Toronto, Ontario
- University College London Hospital — London, No Province
📞 Contact the Study Coordinator
Phone: (416) 736-2100
Email: rpr@yorku.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Acute Pain
- Understanding the Acute Pain Phenotype in Patients Undergoing Surgery — Boston, Massachusetts
- Reducing Pain From Wisdom Molar Extractions — Newark, New Jersey
- Intravenous Ketorolac Vs. Morphine In Children With Acute Abdominal Pain — Calgary, Alberta
- A Study of Combogesic® IV (Intravenous) in Pediatric Patients With Acute Pain — Orlando, Florida
- The Effect of Light Therapy on Post-Surgical Pain — Tucson, Arizona
Explore by condition: All Acute Pain clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.