Assessment of Pain in Newborns and Older Infants (Infant Pain Assessment Study =
NCT ID: NCT03330496
Last Updated: 2022-06-08
Study Results
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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COMPLETED
43 participants
OBSERVATIONAL
2017-10-30
2022-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Preterm infants
preterm neonates (34-37 weeks gestational age, n=15)
Pain Measurement
Measurement of infant responses (behavioral and physiological) during a painful procedure.
Term infants
term newborns (37-42 weeks gestation, n=15)
Pain Measurement
Measurement of infant responses (behavioral and physiological) during a painful procedure.
Small infants
1-3 month-old infants (n=15)
Pain Measurement
Measurement of infant responses (behavioral and physiological) during a painful procedure.
Older infants
3-6 month-old infants (n=15)
Pain Measurement
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
1 Day
6 Months
ALL
No
Sponsors
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Autonomous Healthcare, Inc.
INDUSTRY
Stanford University
OTHER
Responsible Party
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Kanwaljeet Anand
Professor of Pediatrics, Anesthesiology, Perioperative & Pain Medicine
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
Countries
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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.
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.
Other Identifiers
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IRB-39076
Identifier Type: -
Identifier Source: org_study_id
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