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An AI-based Multimodal Approach to Predict Pain in Postnatal Care Scenarios

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HD109086-01A1
Agency Tracking Number: R41HD109086
Amount: $315,169.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NICHD
Solicitation Number: PA21-262
Solicitation Year: 2021
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-08-10
Award End Date (Contract End Date): 2023-07-31
Small Business Information
Tampa, FL 33613-4808
United States
DUNS: 137488446
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (410) 490-2036
Business Contact
Phone: (813) 449-2131
Research Institution
TAMPA, FL 33617-2008
United States

 Nonprofit College or University

Advances in technology and surgical procedures in the past decade have led to a remarkable
increase in numbers of newborns subjected to lifesaving surgery. These postoperative neonates
are customarily triaged to neonatal intensive care units (NICUs) for pain management with
opioids, primarily morphine, fentanyl, and methadone. However, substantial evidence from in-
vitro, animal, and human studies strongly suggests this severe pain-to-opioids regimen causes
long-lasting and likely permanent traumatic harm to the developing neurological systems of
We propose a novel machine learning and computer vision approach for early pain detection
(EPD) with emphasis on postoperative neonates in NICU. By alerting NICU caregivers a minimum
of ~ 30 minutes prior to pain onset, EPD will allow NICU staff to use fast-acting, opioid-sparing
medications, e.g., intravenous paracetamol, ibuprofen, or ketorolac, in conjunction with non-
pharmacological approaches, to “stay ahead of the pain” while avoiding opioid treatments,
tolerance, withdrawal, and their associated side effects.
Our team of NICU specialists, bioscientists, and computer experts will demonstrate proof-of-
concept for reliable EPD in post-surgical neonates using the following aims:
1) Collect clinical information and multimodal data (facial expression, body movement,crying frequency, vital signs) for post-surgical pain prediction in neonates.
We will collect and label multi-modal signals (facial expression, body movements, crying
frequency, vital signs) from ~ 60 neonates in post-surgical pain at the NICU at Tampa General
Hospital (TGH). We will combine these data with similar data from another cohort of ~60 neonates
(total ~ 120 neonates) collected using the same system and approach at TGH from 2019 to 2022.
2) Show proof-of-concept for predicting the onset of post-surgical pain in neonates.
The multimodal data collected from the training cases in Aim 1 will provide the ground truth for
training a convolutional neural network to predict time-to-onset of pain for postoperative neonates
in the testing cases. The performance target for the EPD in the test cases is pain prediction ~ 30
minutes prior to pain onset with a 90% confidence probability. Our intention is to disrupt the current
standard [surgery; sedation; postoperative pain; opioid dependence, tolerance, withdrawal;
discharge] in favor of a safer opioid-sparing approach [surgery; sedation; non-opioid treatment;
discharge]. Our Phase 2 studies will add data from more diverse patient populations and examine
the possible effects of EPD on stress biomarkers, e.g., cortisol, norepinephrine in hair, skin, blood,
or urine. The major benefit to public health will be protection of perhaps the most vulnerable
patient populations from unnecessary damage to their future health and well-being.PROJECT NARRATIVE
Management of postoperative pain in NICUs worldwide follows the standard practice of surgery
then sedation, severe pain, opioid analgesia, opioid dependence, and opioid withdrawal. Two
decades of scientific evidence from in-vitro, animal, and human studies, argue this regimen is
harmful to the newborn, i.e., severe pain and opioid dependence appear to cause long-lasting
and most likely permanent damage to their normal anatomy, physiology, and behavior. We
address this problem with a first-in-industry machine learning and computer vision solution that
achieves early pain detection (EPD) of ~ 30 minutes prior to pain onset, which allows sufficient
time for caregivers to “stay ahead of the pain” with opioid-sparing medications, e.g.,
acetaminophen, ketorolac, ibuprofen, and/or non-pharmacological interventions, and thereby
avoid exposing vulnerable neonates to the harmful effects of postoperative pain, narcotic
analgesia, and opioid withdrawal.

* Information listed above is at the time of submission. *

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