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

Sponsor: York University

NCT ID: NCT05579496

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 124 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at pain care for babies in the neonatal intensive care unit (NICU), exploring skin-to-skin contact and whether computer methods can help improve practice. It has two parts: interviews with parents and NICU staff, and measurements taken from babies during a routine heel lance blood test. It is sponsored by York University.

Who can take part

  • For interviews: parents of a child currently in the NICU, or health professionals currently working in the NICU
  • For baby measurements: infants born between 25 weeks and 0 days and 32 weeks and 6 days of pregnancy (gestational age)
  • Babies within 8 weeks after birth who are having a routine heel lance test

Who may not be able to

  • Interview participants who cannot communicate fluently in English
  • Babies with congenital malformations (problems present from birth)
  • Babies receiving pain-relieving or sedative medicines at the time of the study (except sucrose, a sugar solution)
  • Babies with a history of lack of oxygen or blood flow around birth, at the time of the study
  • Babies with nappy rash or broken skin on the bottom
  • Parents who are not fluent in English

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Taking part involves either an interview (parents and staff) or measurements recorded during a routine heel lance, including video, brain activity (EEG), heart (ECG), breathing rate and oxygen levels — visit numbers and total duration are not stated; ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
25 Weeks to 33 Weeks
Who
All
Number of participants
400
Started
2020-11-01
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for acute pain
  • • Clinical study - 400 participants
  • • 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

Who can take part?

  • • Ages 25 Weeks to 33 Weeks
  • • Diagnosed with acute pain

Where?

  • • London - University College London Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

More detail

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.

Acute Pain

How this trial compares with your answers

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What we know so far

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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 25 Weeks - 33 Weeks
  • Who can join: All genders

What the study is looking for

  • ✓Parents of a child currently in the NICU or
  • ✓Health professionals currently working in the NICU.

Who cannot take part

  • ✗\*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
See the full 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, 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

Where Is This Study? (1 UK site)

University College London Hospital

London N1 2EP, United Kingdom

Recruiting
Site contact (verified)
Lorenzo Fabrizi, PhD02031081888l.fabrizi@ucl.ac.uk

How to Get in Touch

Rebecca Pillai Riddell, PhD

Sponsor contact

CONTACT

4167362100 rpr@yorku.ca

Shah Vibhuti, MD

Sponsor contact

CONTACT

4165864816 Vibhuti.Shah@sinaihealth.ca
Data sourced from ClinicalTrials.gov · Last verified: 2026-07