Rebooting Infant Pain Assessment: Using Machine Learning to Exponentially Improve Neonatal Intensive Care Unit Practice (BabyAI)

York University

Status: Enrolling

Conditions: Acute Pain

Study type: Observational

Funder types: Other

Identifiers

NCT05579496

19-0252-A

Details and patient eligibility

About

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.

Full 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).

Enrollment: 400 estimated patients

Sex: All

Ages: 27 to 33 weeks old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

400 participants in 1 patient group

Infants Hospitalized in the NICU

Description:

Infants born between 28 0/7 weeks 32 6/7 weeks gestational age, who are within 6 weeks postnatal age, and their caregiver and/or health professional will be recruited for qualitative interview.