Recruiting

Observational Study

Sponsor:

York University

Code:

NCT05579496

Conditions

Acute Pain

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Acute Pain

Study ID

NCT05579496

Start date

Nov 1, 2020

Status verified date

Jul, 2026

Completion date

Mar, 2031

Anticipated

Primary completion date

Mar, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Infants Hospitalized in the NICU

Infants born between 25 0/7 weeks 32 6/7 weeks gestational age, who are within 8 weeks postnatal age, and their caregiver (if available) and/or health professional will be recruited for qualitative interview. Infants will participate in the study either in skin-to-skin contact with the birthing parent or in the cot if the parent is unable to participate. If the baby participates in a skin-to-skin study, they will be transferred from the cot to skin-to-skin following EEG electrode placement and a 10-minute cot baseline recording. Babies will be then exposed to a sham lance and a real lance while in skin-to-skin. For cot studies, babies are kept in the cot for the whole study duration, and thus the sham lance and real lance will be conducted while they are in the cot receiving standard care.

Primary outcome measure

  • 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) ]
  • 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) ]
  • Cardiac Correlates of Distress [ Time Frame: Over 2 hours surrounding painful procedure (time locked to heel lance) ]
  • 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) ]
  • 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)] ]

Central Contacts and Locations

Central contacts

Rebecca Pillai Riddell, PhD

4167362100rpr@yorku.ca

Shah Vibhuti, MD

4165864816Vibhuti.Shah@sinaihealth.ca

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

Vibhuti Shah, MD

4165864816Vibhuti.Shah@sinaihealth.ca

Carol Cheng, MSc

carol.cheng@sinaihealth.ca

More Information

Sponsor

York University

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • NICU (Neonatal Intensive Care Unit)
  • Artificial Intelligence
  • Pain Assessment
  • Skin-to-Skin Contact
  • Parent Stress
  • Pain Management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by York University on 2026-07-13.