Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Autonomous Healthcare, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preterm infants | preterm neonates (34-37 weeks gestational age, n=15) |
| |
| Term infants | term newborns (37-42 weeks gestation, n=15) |
| |
| Small infants | 1-3 month-old infants (n=15) |
| |
| Older infants | 3-6 month-old infants (n=15) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pain Measurement | Other | Measurement of infant responses (behavioral and physiological) during a painful procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Measurement (all infants) | Visual Analogue Scale (VAS) measures pain intensity based on observer assessment on a scale from 1 to 10, where higher values indicate more intense pain. | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Measurement | Facial Expressions specific for infant pain will be assessed, including nasolabial furrow and brow bulge. Presence or absence as well as the duration for each facial expression will be recorded during the painful procedure. These facial expressions were chosen from the Neonatal Facial Coding Scale (NFCS) and the Premature Infant Pain Profile (PIPP). | 30 minutes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
We will collect data from 30 study subjects in each of the following age groups:
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kanwaljeet S Anand, MBBS, D.Phil. | Prof. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Packard Children's Hospital Stanford | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40066435 | Derived | Roue JM, Avnit A, Gholami B, Haddad WM, Anand KJS. Objective Detection of Newborn Infant Acute Procedural Pain Using EEG and Machine Learning Algorithms. Paediatr Neonatal Pain. 2025 Mar 10;7(1):e70001. doi: 10.1002/pne2.70001. eCollection 2025 Mar. | |
| 33408199 | Derived | Roue JM, Morag I, Haddad WM, Gholami B, Anand KJS. Using sensor-fusion and machine-learning algorithms to assess acute pain in non-verbal infants: a study protocol. BMJ Open. 2021 Jan 6;11(1):e039292. doi: 10.1136/bmjopen-2020-039292. |
Not provided
Not provided
No data will be shared
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D047928 | Premature Birth |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
Not provided
Not provided
Not provided
Not provided
Not provided
| Pain Measurement (newborns 0-30 days) | Neonatal Pain, Agitation and Sedation Scale (N-PASS) measures level of sedation versus increasing pain or agitation in newborns. Scores range from -10 to +10, where negative scores denote increasing levels of sedation, zero indicates a neutral condition, and positive scores indicate increasing pain intensity and/or agitation. | 5 minutes |
| Pain Measurement (newborns 0-30 days) | Premature Infant Pain Profile - Revised (PIPP-R) measures pain intensity in newborns, with scores ranging from 0 to 21, higher scores indicating greater pain (adjusted for prematurity and behavioral state). | 8 minutes |
| Pain Measurement (infants 1-6 months) | Face, Legs, Activity, Cry, Consolability scale (FLACC scale) measures pain in children between the ages of 2 months and 7 years. The scale is scored in a range of 0-10 with 0 representing no pain and 10 indicating severe pain. | 3 minutes |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |