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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330496
Recruitment Status : Suspended (Analyzing sensor data to eliminate noise/ movement or EM equipment artifacts)
First Posted : November 6, 2017
Last Update Posted : October 1, 2020
Sponsor:
Collaborator:
Autonomous Healthcare, Inc.
Information provided by (Responsible Party):
Kanwaljeet Anand, Stanford University

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.

Condition or disease Intervention/treatment
Pain, Acute Other: Pain Measurement

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Using Machine-learning Algorithms to Assess Acute Pain in Nonverbal Infants
Actual Study Start Date : October 30, 2017
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : December 2026

Group/Cohort Intervention/treatment
Preterm infants
preterm neonates (34-37 weeks gestational age, n=15)
Other: Pain Measurement
Measurement of infant responses (behavioral and physiological) during a painful procedure.

Term infants
term newborns (37-42 weeks gestation, n=15)
Other: Pain Measurement
Measurement of infant responses (behavioral and physiological) during a painful procedure.

Small infants
1-3 month-old infants (n=15)
Other: Pain Measurement
Measurement of infant responses (behavioral and physiological) during a painful procedure.

Older infants
3-6 month-old infants (n=15)
Other: Pain Measurement
Measurement of infant responses (behavioral and physiological) during a painful procedure.




Primary Outcome Measures :
  1. Pain Measurement (all infants) [ Time Frame: 10 minutes ]
    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.


Secondary Outcome Measures :
  1. Pain Measurement [ Time Frame: 30 minutes ]
    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).

  2. Pain Measurement (newborns 0-30 days) [ Time Frame: 5 minutes ]
    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.

  3. Pain Measurement (newborns 0-30 days) [ Time Frame: 8 minutes ]
    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).

  4. Pain Measurement (infants 1-6 months) [ Time Frame: 3 minutes ]
    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.



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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330496


Locations
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United States, California
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Autonomous Healthcare, Inc.
Investigators
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Principal Investigator: Kanwaljeet S Anand, MBBS, D.Phil. Prof.
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Responsible Party: Kanwaljeet Anand, Professor of Pediatrics, Anesthesiology, Perioperative & Pain Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT03330496    
Other Study ID Numbers: IRB-39076
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No data will be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kanwaljeet Anand, Stanford University:
infant-newborn
infant-premature
pain
acute pain
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations