Rebooting Infant Pain Assessment: Using Machine Learning to Exponentially Improve Neonatal Intensive Care Unit Practice

ConditionAcute Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age27-33
SponsorYork University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

QUALITATIVE INTERVIEWS

parents of a child currently in the NICU or

health professionals currently working in the NICU.

Disqualifiers

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

Trial population

Preterm infants

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 1 trial group
Group A: Infants Hospitalized in the NICU

Trial outcomes

Primary outcomes

1

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)

Time frame
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)
2

Cortical Correlate of Distress

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

Time frame
For 2 hours surrounding Painful procedure (time locked to heel lance; approximately 1 hour before to 1 hour after heel lance)
3

Cardiac Correlates of Distress

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

Time frame
Over 2 hours surrounding Painful procedure (time locked to heel lance)
4

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

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

1

Semi-Structured Interview

Health Professionals and Caregivers will be asked about their thoughts on using AI for infant pain assessment

Time frame
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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

York University

Lead sponsor

MOUNT SINAI HOSPITAL

Collaborator

University College, London

Collaborator

University College London Hospitals

Collaborator

University of Calgary

Collaborator

McMaster University

Collaborator