Rebooting Infant Pain Assessment: Using Machine Learning 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

A multi-national multidisciplinary team will be working collaboratively to build a machine learning algorithm to distinguish between preterm infant distress states in the Neonatal Intensive Care Unit.

Conditions

Acute Pain

Keywords

NICU (Neonatal Intensive Care Unit); Artificial Intelligence; Pain Assessment

Outcome Measures

Primary Outcomes (4)

• 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., in preparation)

  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)

Secondary Outcomes (1)

• Semi-Structured Interview

  These interviews are occurring at the beginning of the study and will be qualitatively analyzed. They are not linked to infants whose data we are collecting primary outcomes.

Study Arms (1)

Infants Hospitalized in the NICU

Infants born between 28 0/7 weeks 32 6/7 weeks gestational age, who are within 6 weeks postnatal age, and their caregiver and/or health professional will be recruited for qualitative interview.

Eligibility Criteria

• Age: 27 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, SPo2)
• 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
• 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

Sponsors & Collaborators

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

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rebecca Pillai Riddell, PhD

  York University/Mount Sinai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Pillai Riddell, PhD

CONTACT

416736200; rpr@yorku.ca

Lorenzo Fabrizi, PhD

CONTACT

02031081888; l.fabrizi@ucl.ac.uk

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: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); GB (1)