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

NCT ID: NCT03330496

Last Updated: 2022-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-30

Study Completion Date

2022-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pain, Acute

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Preterm infants

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

Pain Measurement

Intervention Type OTHER

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

Term infants

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

Pain Measurement

Intervention Type OTHER

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

Small infants

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

Pain Measurement

Intervention Type OTHER

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

Older infants

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

Pain Measurement

Intervention Type OTHER

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

Interventions

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Pain Measurement

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 1\. 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.

Exclusion Criteria

1. 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.
2. 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.
3. Newborns and infants requiring positive pressure ventilation using a face mask (BiPAP) or endotracheal tube (conventional or high-frequency ventilators).
4. 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).
5. Newborns and infants with facial anomalies, injuries or other pathologies affecting the facial area.
Minimum Eligible Age

1 Day

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Autonomous Healthcare, Inc.

INDUSTRY

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Kanwaljeet Anand

Professor of Pediatrics, Anesthesiology, Perioperative & Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kanwaljeet S Anand, MBBS, D.Phil.

Role: PRINCIPAL_INVESTIGATOR

Prof.

Locations

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Lucile Packard Children's Hospital Stanford

Palo Alto, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40066435 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33408199 (View on PubMed)

Other Identifiers

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IRB-39076

Identifier Type: -

Identifier Source: org_study_id

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