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

NCT03330496 | Completed

• 1 other identifier: IRB-39076
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Acute

Keywords

infant-newborn; infant-premature; pain; acute pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Pain Measurement

  30 minutes

• Pain Measurement (newborns 0-30 days)

  5 minutes

• Pain Measurement (newborns 0-30 days)

  8 minutes

• Pain Measurement (infants 1-6 months)

  3 minutes

Study Arms (4)

Preterm infants

preterm neonates (34-37 weeks gestational age, n=15)

Other: Pain Measurement

Term infants

term newborns (37-42 weeks gestation, n=15)

Other: Pain Measurement

Small infants

1-3 month-old infants (n=15)

Other: Pain Measurement

Older infants

3-6 month-old infants (n=15)

Other: Pain Measurement

Interventions

Pain Measurement OTHER

Measurement of infant responses (behavioral and physiological) during a painful procedure.

Older infants; Preterm infants; Small infants; Term infants

Eligibility Criteria

• Age: 1 Day - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

We will collect data from 30 study subjects in each of the following age groups: * Preterm infants (34-37 weeks, postnatal age 3-30 days) * Term newborns (37-42 weeks gestation, less than 1 month of age) * Infants from 1-3 months age, and * Older infants from 3-6 months age. A total of 120 subjects will be recruited before study closure.

You may qualify if:

• \. All infants less than 6 months of corrected chronological age. 2. Infants admitted to the participating ICUs at LPCH (NICU, PICU, CVICU). 3. Require an acute painful procedure for routine clinical care.

You may not qualify if:

• Newborns with birth trauma, intrapartum asphyxia (5-minute Apgar Score \<4 or cord pH \< 7.01), fetal growth restriction (birth weight \< 5th percentile for gestation), congenital anomalies or metabolic disorders, or any kind of brain injury.
• Newborns born to mothers with a history of heavy smoking or drug abuse (alcohol, cocaine, ketamine, heroin/other opiates) or psychiatric drugs used during this pregnancy.
• Newborns and infants requiring positive pressure ventilation using a face mask (BiPAP) or endotracheal tube (conventional or high-frequency ventilators).
• Newborns and infants receiving continuous infusions of opioid drugs (morphine, fentanyl, others) and nerve blocks or neuraxial analgesia affecting the site of the invasive procedure during the 24 hours prior to study entry. (Note: Infants receiving intermittent opioids or non-opioid analgesics (acetaminophen, ibuprofen, ketorolac, others) WILL NOT be excluded).
• Newborns and infants with facial anomalies, injuries or other pathologies affecting the facial area.

Sponsors & Collaborators

• Stanford University: lead
• Autonomous Healthcare, Inc.: collaborator

Study Sites (1)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Location

Related Publications (2)

• 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.

  PMID: 40066435 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.

  PMID: 33408199 DERIVED

MeSH Terms

Conditions

Acute Pain; Premature Birth; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Kanwaljeet S Anand, MBBS, D.Phil.

  Prof.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics, Anesthesiology, Perioperative & Pain Medicine

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: November 6, 2017
• Study Start: October 30, 2017
• Primary Completion: April 29, 2021
• Study Completion: March 30, 2022
• Last Updated: June 8, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)