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

ConditionAcute Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age25-33
SponsorYork University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Parents of a child currently in the NICU or

Health professionals currently working in the NICU.

Disqualifiers

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

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., 2022, 10.1097/j.pain.0000000000002798)

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

Birthing Parent Heart Rate and Respiration Rate

We will measure parent cardiac stress in order to control for the effect of the parent context on infant pain processing. We will collect ECG data with 3 leads and a thin belt for respiration from the CNS monitor.

Time frame
[Time Frame: Over 1.5 hours surrounding painful procedure (time locked to heel lance)]
2

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

* Gestational age at birth, post menstrual age at study, and postnatal age * Birthweight * Current weight * Sex * Birth order * Type of delivery and any resuscitation required * Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) scores at birth (1 and 5 minutes) * SNAP II scores * Ventilation requirements * Type and time of last feed * What indwelling devices are present during the study * Area or location of study * Diagnoses (active problems in the last 72h and any diagnosis that have now resolved \[\>72h\]) * Antenatal history * Brain imaging (cranial ultrasound) * Acute procedure history (type, per day, number of attempts) * Amount of skin to skin per day * Hours since last skin-breaking procedure \& number of skin-breaking procedures in the 48-hours preceding the heel lance * Total doses of sucrose \& sucrose at time of study * Drug classes at time of heel lance

Time frame
Extracted from participants' medical charts following study completion
3

Chart Review of Cumulative Painful Procedures

We will collect data on the cumulative exposure of painful and/or invasive procedures that the infant experienced since birth. A published tool will be used to calculate total pain burden during their NICU stay (Laudiano-Dray et al., 2020; 10.1097/j.pain.0000000000001814).

Time frame
Extracted from participants' medical charts following study completion
4

Parent Self-Report Questionnaires

Four questionnaires will be completed to understand the perspectives and experiences of birthing parents at time of study: 1. Participant Information Sheet (PIS) - quantifies socio-economic status, ethnic background, and familial characteristics of the sample. 2. Parental Stress Scale: NICU (PSS:NICU) - measures NICU specific stress 3. Experiences in Close Relationships Scale (ECR) - measures adult attachment patterns 4. Perceived Stress Scale (PSS) - measures general stress levels

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

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