Neonatal Pain Management Study

Developing Al-Driven Pain Intensity and Pain Sensitization Biomarker Signatures to Optimize Neonatal Pain Management

Newborns in the neonatal intensive care unit (NICU) undergoing invasive procedures or surgeries are frequently exposed to prolonged pain, postoperative complications, and human suffering because of the major difficulties in measuring neonatal pain. This leads to inconsistent and ineffective pain management, delayed pain treatments due to nursing workload, and controversies among the medical or nursing staff who have different ways of defining pain.  Surgical injury also triggers hyper-excitability of nociceptive pathways in the adult and infant spinal cord; this “central sensitization” lasts longer in newborns and alters their pain processing pathways, thus increasing their vulnerability to chronic pain in later life. 

Our proposed research aims to develop an automated system to objectively and continuously measure newborn pain and pain sensitization following surgery, based on several objective biomarkers.  When acute pain is detected, pain alarms will be sent to their bedside nurses in real-time. The proposed neonatal pain monitoring system (NPMS) allows us to create therapeutic strategies that minimize pain, stress, and total opioid doses given during the post-operative care of newborns, thereby improving their clinical and post-surgical outcomes.

Using our artificial intelligence/machine learning (AI/ML) algorithms developed for neonatal pain, the UG3 phase will identify AI-driven biomarker signatures for surgical pain and pain sensitization in neonates and develop a protocol to minimize postoperative pain. The UH3 phase will complete a randomized controlled trial (RCT) using postoperative pain scores, clinical outcomes, pain-related stress, acute pain events, pain trajectories, and provider surveys to compare the two randomized groups with and without AI-driven pain monitoring. This RCT will inform the design of a definitive, pivotal Phase III RCT to promote widespread adoption of this novel approach by the NICU health care community.

Coordinating Center: University of South Florida

MPI: Dr. Yu Sun

Co-PI: Dr. Kanwaljeet S. Anand

Site PI: Dr. Melissa Scala