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

NCT05579496 | Recruiting

• 1 other identifier: 19-0252-A
• Study Type: observational
• Target: 400
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Acute Pain

Keywords

NICU (Neonatal Intensive Care Unit); Artificial Intelligence; Pain Assessment; Skin-to-Skin Contact; Parent Stress; Pain Management

Outcome Measures

Primary Outcomes (5)

• Behavioural Correlate of Distress

  To be analyzed using machine learning via bedside videography: Facial Grimacing using Neonatal Facial Coding System (NFCS-P subset; Bucsea et al., 2022, 10.1097/j.pain.0000000000002798)

  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)

• Cortical Correlate of Distress

  To be analyzed using machine learning via bedside monitoring: Continuous EEG data capture

  For 2 hours surrounding painful procedure (time locked to heel lance; approximately 1 hour before to 1 hour after heel lance)

• Cardiac Correlates of Distress

  To be analyzed using machine learning via bedside monitoring: Heart Rate, Heart Rate Variability

  Over 2 hours surrounding painful procedure (time locked to heel lance)

• Oxygen Saturation Correlate of Distress

  To be analyzed using machine learning via bedside monitoring: amount of oxygen-carrying hemoglobin in the blood relative to the amount of hemoglobin not carrying oxygen

  Over 2 hours surrounding painful procedure (time locked to heel lance; approximately 1 hour before to 1 hour after heel lance)

• Respiration Rate Correlate of Distress

  To be analyzed using machine learning via bedside monitoring: Respiratory patterns

  [Time Frame: Over 2 hours surrounding painful procedure (time locked to heel lance; approximately 1 hour before to 1 hour after heel lance)]

Secondary Outcomes (6)

• Birthing Parent Heart Rate and Respiration Rate

  [Time Frame: Over 1.5 hours surrounding painful procedure (time locked to heel lance)]

• Chart review of general health indicators and other NICU experiences (control as potential confounders), such as:

  Extracted from participants' medical charts following study completion

• Chart Review of Cumulative Painful Procedures

  Extracted from participants' medical charts following study completion

• Parent Self-Report Questionnaires

  Completed at the beginning of the study while EEG electrodes are being applied to the baby

• Detailed documentation of noxious and sham stimulation details: (Control for their influence on infant responses)

  Documented following the study completion

Study Arms (1)

Infants Hospitalized in the NICU

Infants born between 25 0/7 weeks 32 6/7 weeks gestational age, who are within 8 weeks postnatal age, and their caregiver (if available) and/or health professional will be recruited for qualitative interview. Infants will participate in the study either in skin-to-skin contact with the birthing parent or in the cot if the parent is unable to participate. If the baby participates in a skin-to-skin study, they will be transferred from the cot to skin-to-skin following EEG electrode placement and a 10-minute cot baseline recording. Babies will be then exposed to a sham lance and a real lance while in skin-to-skin. For cot studies, babies are kept in the cot for the whole study duration, and thus the sham lance and real lance will be conducted while they are in the cot receiving standard care.

Eligibility Criteria

• Age: 25 Weeks - 33 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants

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)
• 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
• 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

Sponsors & Collaborators

• York University: lead
• MOUNT SINAI HOSPITAL: collaborator
• University College, London: collaborator
• University College London Hospitals: collaborator

Study Sites (2)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

RECRUITING

University College London Hospital

London, No Province, N1 2EP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Acute Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Rebecca Pillai Riddell, PhD

  York University/Mount Sinai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Pillai Riddell, PhD

CONTACT

4167362100; rpr@yorku.ca

Shah Vibhuti, MD

CONTACT

4165864816; Vibhuti.Shah@sinaihealth.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: December 24, 2020
• First Posted: October 13, 2022
• Study Start: November 1, 2020
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2031
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); GB (1)