Rebooting Infant Pain Care: Using Machine Learning and Skin-to-Skin Contact to Exponentially Improve Neonatal Intensive Care Unit Practice

Recruiting now

Conditions studied: Acute Pain

In brief

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.

Key facts

Study ID

NCT05579496

Run by

York University

People needed

400

Starts

2020-11-01

Expected to finish

2031-03-01

Last updated by the study team

2026-07-13

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Parents of a child currently in the NICU or
• Health professionals currently working in the NICU.

You may not qualify if…

• 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 is running

• Mount Sinai Hospital — Toronto, Ontario, Canada (enrolling)
• University College London Hospital — London, No Province, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.