Clinical trial NCT05579496: Rebooting Infant Pain Assessment: Using Machine Learning to Exponentially Improve Neonatal Intensive Care Unit Practice
Official title: Rebooting Infant Pain Assessment: Using Machine Learning to Exponentially Improve Neonatal Intensive Care Unit Practice
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Pain
Keywords: NICU (Neonatal Intensive Care Unit)
Artificial Intelligence
Pain Assessment
Lead sponsor: York University
Sponsor class: OTHER
Collaborators: name: MOUNT SINAI HOSPITAL
name: University College, London
name: University College London Hospitals
name: University of Calgary
name: McMaster University
First posted: 2022-10-13
Enrollment: 400
Sex: ALL
Minimum age (years): 27
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants

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.

Detailed 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).

Eligibility criteria: * 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

Primary outcomes:
measure: Behavioural Correlate of Distress
timeFrame: 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)
measure: Cortical Correlate of Distress
timeFrame: For 2 hours surrounding Painful procedure (time locked to heel lance; approximately 1 hour before to 1 hour after heel lance)
measure: Cardiac Correlates of Distress
timeFrame: Over 2 hours surrounding Painful procedure (time locked to heel lance)
measure: Oxygen Saturation Correlate of Distress
timeFrame: Over 2 hours surrounding Painful procedure (time locked to heel lance; approximately 1 hour before to 1 hour after heel lance)
Secondary outcomes:
measure: Semi-Structured Interview
timeFrame: 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:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: London
country: United Kingdom
facility: University College London Hospital
state: No Province
Study officials:
affiliation: York University/Mount Sinai Hospital
name: Rebecca Pillai Riddell, PhD
role: PRINCIPAL_INVESTIGATOR
References: