NCT03330496: iPAS)

Assessment of Pain in Newborns and Older Infants (Infant Pain Assessment Study =

Completed Last updated 8 June 2022

What this trial tests

trial testing Pain Measurement in Pain, Acute in 43 participants. Completed in 30 March 2022.

Timeline

30 October 2017

Primary endpoint
29 April 2021

30 March 2022

Quick facts

Lead sponsor	Stanford University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	43
Start date	30 October 2017
Primary completion	29 April 2021
Estimated completion	30 March 2022
Sites	1 location across United States

Drugs / interventions tested

• Pain Measurement

Conditions studied

• Pain, Acute — all drugs for Pain, Acute →

Sponsor

Stanford University

Who can join

Adults 1 Day to 6 Months, any sex, with Pain, Acute. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pain assessments in non-verbal, critically ill infants represent an important clinical challenge. Older children or adults can easily express their pain, but infants lack that capability. They frequently experience repetitive acute pain during routine ICU care, but their analgesic management flounders on the horns of a dilemma: (a) failure to treat infant pain leads to immediate clinical instability and potentially long-term physical, behavioral, and cognitive sequelae, vs. (b) strong analgesics may increase risks for medical complications and/or impaired brain growth. Bedside nurses currently assess pain using pain scores, before taking action to ameliorate pain. Pain scores increase nursing workload and provide subjective assessments, rather than objective data for evaluating infant pain. Consequently, infants exposed to skin-breaking procedures, surgery, or other painful conditions often receive variable and inconsistent pain management in the ICU. The investigators aim to develop a multimodal pain assessment system, using sensor fusion and novel machine learning algorithms to provide an objective measure of pain that is context-dependent and rater-independent. This will enhance the quality of pain management in ICUs and allow continuous pain monitoring in real-time.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The past, current, and future of neonatal intensive care units with artificial intelligence: a systematic review.
   Keles E, Bagci U. · · 2023 · cited 36× · PMID 38012349 · DOI 10.1038/s41746-023-00941-5
2. Using sensor-fusion and machine-learning algorithms to assess acute pain in non-verbal infants: a study protocol.
   Roué JM, Morag I, Haddad WM, Gholami B, et al · · 2021 · cited 14× · PMID 33408199 · DOI 10.1136/bmjopen-2020-039292
3. Objective Detection of Newborn Infant Acute Procedural Pain Using EEG and Machine Learning Algorithms.
   Roué JM, Avnit A, Gholami B, Haddad WM, et al · · 2025 · PMID 40066435 · DOI 10.1002/pne2.70001