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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Acute Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Infants Hospitalized in the NICU

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* parents of a child currently in the NICU or
* health professionals currently working in the NICU.
* 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

* Participants who cannot communicate fluently in English
* QUANTITITATIVE DATA CAPTURE (video, eeg, ecg, SPo2)
* 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

Minimum Eligible Age

27 Weeks

Maximum Eligible Age

33 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No