Pain, AcuteiPAS)NCT03330496
Assessment of Pain in Newborns and Older Infants (Infant Pain Assessment Study =
An observational study of Pain, Acute, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 6 months
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Pain Measurement
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2017to 30 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 6 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304
About this study
Official title: Using Machine-learning Algorithms to Assess Acute Pain in Nonverbal Infants
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
- Being tested
- Pain Measurement
- Keywords
- infant-newborn, infant-premature, pain, acute pain
- Medical subject headings
- Acute Pain, Premature Birth, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain MeasurementOther
Measurement of infant responses (behavioral and physiological) during a painful procedure.
| Study group | Role | What they receive |
|---|---|---|
| Preterm infants | preterm neonates (34-37 weeks gestational age, n=15) Receives: Other: Pain Measurement | |
| Term infants | term newborns (37-42 weeks gestation, n=15) Receives: Other: Pain Measurement | |
| Small infants | 1-3 month-old infants (n=15) Receives: Other: Pain Measurement | |
| Older infants | 3-6 month-old infants (n=15) Receives: Other: Pain Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes
Secondary outcomes (4)
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).
Measured: 30 minutes
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.
Measured: 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).
Measured: 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.
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start30 Oct 2017
- Primary completion29 Apr 2021
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Autonomous Healthcare, Inc.
- Responsible party
- Principal investigator, Kanwaljeet Anand, Stanford University
- Investigators
- Kanwaljeet S Anand, MBBS, D.Phil., Principal investigator, Prof.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330496
- Sponsor's protocol ID
- IRB-39076
- Acronym
- iPAS)
- Status last verified
- Jun 2022
- First submitted
- 24 Oct 2017
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data will be shared
Publications
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.
PubMed 40066435Roue 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.
PubMed 33408199
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Machine-learning Algorithms to Assess Acute Pain in Nonverbal Infants
- ClinicalTrials.gov ID
- NCT03330496
- Acronym / sponsor ID
- iPAS) / IRB-39076
- Conditions
- Pain, Acute
- Keywords
- infant-newborn, infant-premature, pain, acute pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Autonomous Healthcare, Inc.
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 29 Apr 2021 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Preterm infants | – | Other: Pain Measurementpreterm neonates (34-37 weeks gestational age, n=15) |
| Term infants | – | Other: Pain Measurementterm newborns (37-42 weeks gestation, n=15) |
| Small infants | – | Other: Pain Measurement1-3 month-old infants (n=15) |
| Older infants | – | Other: Pain Measurement3-6 month-old infants (n=15) |
Who may qualify
- Ages
- 1 day to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain MeasurementMeasurement of infant responses (behavioral and physiological) during a painful procedure. | Other | Older infants, Preterm infants, Small infants, Term infants |
Primary outcome
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.
4 secondary outcomes
Pain Measurement
Time frame: 30 minutes
Pain Measurement (newborns 0-30 days)
Time frame: 5 minutes
Pain Measurement (newborns 0-30 days)
Time frame: 8 minutes
Pain Measurement (infants 1-6 months)
Time frame: 3 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Derived from this study: PubMed 40066435Roue 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.
- Derived from this study: PubMed 33408199Roue 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.
- Individual participant dataSharing planned: No. No data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kanwaljeet S Anand, MBBS, D.Phil. principal investigator
Prof.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Acute, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Measurement (all infants) (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03330496, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.