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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05579496
Other study ID # 19-0252-A
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2020
Est. completion date December 2026

Study information

Verified date October 2022
Source York University
Contact Rebecca Pillai Riddell, PhD
Phone 416736200
Email rpr@yorku.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Unmanaged pain in hospitalized infants has serious long-term complications. 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. A sample of 400 preterm infants (300 from Mount Sinai Hospital and 100 from University College London Hospital [UCLH]) and their mothers will be followed during a routine painful procedure (heel lance). Pain indicators (facial grimacing [behavioural indicators], heart rate, oxygen saturation levels [physiologic indicators], brain electrical activity) during the painful procedure will be used to train the algorithm to discriminate between different types of distress (pain-related and non-pain related).


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date December 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 27 Weeks to 33 Weeks
Eligibility - 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, SPo2) - Inclusion Criteria: - 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 - 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Mount Sinai Hospital Toronto Ontario
United Kingdom University College London Hospital London No Province

Sponsors (6)

Lead Sponsor Collaborator
York University McMaster University, MOUNT SINAI HOSPITAL, University College London Hospitals, University College, London, University of Calgary

Countries where clinical trial is conducted

Canada,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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)
Primary 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 Semi-Structured Interview Health Professionals and Caregivers will be asked about their thoughts on using AI for infant pain assessment 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.
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