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NCT Number: NCT05579496

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

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.

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Key information

Conditions

Acute Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

25 week–33 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Mount Sinai Hospital, Toronto, Ontario, Canada

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About this study

Unmanaged pain in hospitalized infants has serious long-term complications. Existing infant pain assessment approaches demonstrate several key flaws (e.g., dependent on human cognitive capacity to simply combine data from multiple indicators into a total pain score, none have passed a critical discriminant validity test, bias introduced from human caregivers). Thus, the complexity of preterm pain assessment necessitates a machine learning approach. 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, better understanding how skin-to-skin contact works in caregiver-infant dyads and factors that influence the effectiveness of this pain management strategy is a critical step in improving infant pain care in NICUs. Relatedly, the design and sample of our current study (acute pain paradigm while infant is either in skin-to-skin contact with the birthing parent or in the cot) allows us to not only test the influence of skin-to-skin contact vs. cot on preterm newborn pain responding, but also interrogate potential mechanisms underlying the effectiveness of skin-to-skin contact (i.e., cardiac regulation attunement between caregivers and their infants during the procedure; influence of birthing parent perceived stress given the particularly elevated stress levels of NICU parents). A sample of 400 preterm infants (300 from Mount Sinai Hospital and 100 from University College London Hospital [UCLH]) and their birthing parents (if available) will be followed during a routine painful procedure (heel lance). Pain indicators (facial grimacing [behavioural indicators], heart rate, respiration 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). Heart rate and respiration rate, as well as maternal-reported perceived stress levels, will be collected from the birthing parent to examine factors impacting the effectiveness of skin-to-skin contact.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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, RR, SPo2)

Inclusion criteria

  • 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

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
  • Parents who are not fluent in English

Treatment and study plan

Primary outcomes

  1. Behavioural Correlate of Distress

    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)

    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)

  2. Cortical Correlate of Distress

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

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

  3. Cardiac Correlates of Distress

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

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

  4. Oxygen Saturation Correlate of Distress

    Time frame: Over 2 hours surrounding painful procedure (time locked to heel lance; approximately 1 hour before to 1 hour after heel lance)

    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

  5. Respiration Rate Correlate of Distress

    Time frame: [Time Frame: Over 2 hours surrounding painful procedure (time locked to heel lance; approximately 1 hour before to 1 hour after heel lance)]

    To be analyzed using machine learning via bedside monitoring: Respiratory patterns

Secondary outcomes

  1. Birthing Parent Heart Rate and Respiration Rate

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

    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.

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

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

    • 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

  3. Chart Review of Cumulative Painful Procedures

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

    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).

  4. Parent Self-Report Questionnaires

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

    Four questionnaires will be completed to understand the perspectives and experiences of birthing parents at time of study:

    • Participant Information Sheet (PIS) - quantifies socio-economic status, ethnic background, and familial characteristics of the sample.
    • Parental Stress Scale: NICU (PSS:NICU) - measures NICU specific stress
    • Experiences in Close Relationships Scale (ECR) - measures adult attachment patterns
    • Perceived Stress Scale (PSS) - measures general stress levels

  5. Detailed documentation of noxious and sham stimulation details: (Control for their influence on infant responses)

    Time frame: Documented following the study completion

    • Time of lance/sham
    • Stimulation site
    • Infant position
    • Exact monitoring measurements taken or failed
    • Sleep/wake states
    • Any cuts visible on the heels (including the other heel not lanced)
    • Maternal position
    • Degree of skin contact
    • Blood test required for the lance and volume
    • Whether heel was squeezed during lance and duration (if applicable)

  6. Semi-Structured Interview

    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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca Pillai Riddell, PhD

CONTACT

[email protected]

4167362100 ext. ext. 20177

Shah Vibhuti, MD

CONTACT

[email protected]

4165864816

Sponsors and collaborators

Lead sponsor

York University

Other

Collaborators

  • MOUNT SINAI HOSPITAL
  • University College London Hospitals
  • University College, London

Registry information

Acronym: BabyAIBabyCalm

Important dates

Study start
2020
Primary completion
2030
Study completion
2031
First posted
Oct 13, 2022
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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