Pain, PostoperativeNCT03057782
Innovative Approaches to Assessment of Pain Control and Sedation in the NICU
An observational study of Pain, Postoperative, run by Boston Children's Hospital at 1 site in United States.
Trial summary
It is difficult to assess pain and agitation in the NICU population because for a multitude of reasons including the pre-verbal nature of the patient population, the atypical pain response of premature infants, and the use of muscle relaxing medications that exclude motor response in pain assessments. Read more about this study
- Who is it for?
- Ages 1 hour to 6 months
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Waveguard (TM) EEG cap, Micro Movement Sensor and Pico Movement Sensor
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Sep 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 hour to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: This is a prospective, non-interventional study designed to assess neurophysiologic responses and clinical signs to noxious and non-noxious stimuli following procedural pain in infants requiring NICU care following elective surgery. Simultaneous measures of neurophysiological, autonomic and behavioral responses to non-noxious and clinically-required noxious stimuli will be collected from patients in the NICU.
Who may be able to join
- All patients will be admitted to the NICU, and having a post-menstrual age of >28 weeks. Participants will be divided into four groups according to the following criteria:
- Group A
- Plan for major surgery anticipated to cause pain and agitation (i.e. esophageal atresia treatment);
- Patients who are anticipated to receive prolonged post-surgical neuromuscular blockade
- Group B
- Plan for major surgery anticipated to cause pain and agitation (i.e. bowel surgery);
Show all 9Show fewer
- Patients who are not anticipated to receive acute post-surgical neuromuscular blockade
- Group C Plan for minor surgery anticipated to cause pain and agitation (i.e. hernia repair);
- Group D No plan for surgery
Who cannot join
- Confirmed or suspected clinical seizures
- Metabolic abnormalities or inborn error of metabolism
- Skin abrasions or wounds located at the site of research sensor placement i.e. scalp, which interfere with the application of electrodes
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
It is difficult to assess pain and agitation in the NICU population because for a multitude of reasons including the pre-verbal nature of the patient population, the atypical pain response of premature infants, and the use of muscle relaxing medications that exclude motor response in pain assessments. Current assessment tools are based on physical exam and vital signs. The investigators propose to study the role of EEG and palmar conductance (PD) as additional tools in the assessment of pain and agitation
Read the detailed description
This is a prospective, non-interventional study designed to assess noxious-specific neurophysiologic responses and clinical signs following procedural pain in infants requiring hospitalization in the neonatal intensive care unit (NICU) following elective surgery.
The main goal of the study is to develop a method that reliably quantifies the level of pain induced from clinically-required noxious procedures to infants hospitalized in the NICU. This method will use measures of neurophysiological, autonomic, and behavioral responses to non-noxious and clinically-required noxious stimuli in order to guide the pharmacological treatment of NICU patients with analgesic agents, sedatives and/or muscle relaxants.
The investigators hypothesize that resting state activity and physiological responses to noxious and non-noxious stimuli provide a more reliable assessment of the level of pain of infants hospitalized in the NICU compared to behavioral-based pain scores.
- Conditions
- Pain, Postoperative
- Being tested
- Waveguard (TM) EEG cap, Micro Movement Sensor, Pico Movement Sensor, QS Piezostimulator, tactileTM sensory evaluator
- Keywords
- Pain, Sedation, Surgery
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Waveguard (TM) EEG capDevice
The device is an EEG cap - a non-invasive EEG positioning system used to quickly place a large number of surface electrodes in a quick and consistent manner on the head. The device will measure electrophysiological signals from the scalp at the time points in the study listed in the protocol.
Micro Movement SensorDevice
This device is not FDA approved. This device is in clinical use for all age groups and used for research purposes by neurologists, physiologists and anesthesiologists. In this study, the device is used to monitor breathing and movement in children; the device is not used for validation purposes.
Pico Movement SensorDevice
This device is not FDA approved. This device is in clinical use for all age groups and used for research purposes by neurologists, physiologists and anesthesiologists. In this study, the device is used to monitor respiration rate and gross body movement in children. The device will not be used for validation purposes.
QS PiezostimulatorDevice
This device is not FDA approved. This device is used for research purposes by neurologists and physiologists. It is a mechanical tactile stimulator for use in functional imaging experiments like MEG, fMRI or EEG. The stimulation is realized by using several different pin matrices. In this study, the device is used to stimulate the children's extremities in order to elicit somatosensory evoked responses.
tactileTM sensory evaluatorDevice
This device is not FDA approved. This device is used for clinical and research purposes by neurologists and physiologists. It is used to stimulate the children's extremities in order to elicit somatosensory evoked responses.
| Study group | Role | What they receive |
|---|---|---|
| Group A | 1. Plan for major surgery anticipated to cause pain and agitation (i.e. esophageal atresia treatment);
2. Patients who are anticipated to receive prolonged post-surgical neuromuscular blockade (NMB)
The following devices will be used in this Group: Waveguard (TM) EEG cap; Micro Movement Sensor; Pico Movement Sensor; QS Piezostimulator; tactileTM sensory evaluator. These subjects will also receive EMG monitoring. Subjects in this group will also have video recordings that may be used for novel analysis such as subdermal blood flow or micro-movement. Receives: Device: Waveguard (TM) EEG cap; Device: Micro Movement Sensor; Device: Pico Movement Sensor; Device: QS Piezostimulator; Device: tactileTM sensory evaluator | |
| Group B | 1. Plan for major surgery anticipated to cause pain and agitation (i.e. bowel surgery);
2. Patients who are not anticipated to receive acute post-surgical NMB
The following devices will be used in this Group: Waveguard (TM) EEG cap; Micro Movement Sensor; Pico Movement Sensor; QS Piezostimulator; tactileTM sensory evaluator. Subjects in this group will also have video recordings that may be used for novel analysis such as sub-dermal blood flow or micro-movement. Receives: Device: Waveguard (TM) EEG cap; Device: Micro Movement Sensor; Device: Pico Movement Sensor; Device: QS Piezostimulator; Device: tactileTM sensory evaluator | |
| Group C | Plan for minor surgery anticipated to cause pain and agitation (i.e. hernia repair)
The following devices will be used in this Group: Waveguard (TM) EEG cap; Micro Movement Sensor; Pico Movement Sensor; QS Piezostimulator; tactileTM sensory evaluator. Subjects in this group will also have video recordings that may be used for novel analysis such as sub-dermal blood flow or micro-movement. Receives: Device: Waveguard (TM) EEG cap; Device: Micro Movement Sensor; Device: Pico Movement Sensor; Device: QS Piezostimulator; Device: tactileTM sensory evaluator | |
| Group D | No plan for surgery
The following devices will be used in this Group: Waveguard (TM) EEG cap; Micro Movement Sensor; Pico Movement Sensor; QS Piezostimulator; tactileTM sensory evaluator. Subjects in this group will also have video recordings that may be used for novel analysis such as sub-dermal blood flow or micro-movement. Receives: Device: Waveguard (TM) EEG cap; Device: Micro Movement Sensor; Device: Pico Movement Sensor; Device: QS Piezostimulator; Device: tactileTM sensory evaluator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Noxious Stimuli Results
To assess pain-specific brain activity and autonomic responses post surgery in response to an acute noxious procedure in newborn infants admitted to the NICU. This outcome will be correlated with current behavioral and physiological based pain assessment tools as follows:
Procedural-specific brain activity in infants with varying conditions with pre or post-operative pain. EEG: amplitude of noxious-event related potential evoked by a time-locked noxious stimulus. Pain-specific electro-dermal activity (EDA), electromyography (EMG) and subdermal skin flow; Pain-evoked behavioral measures including: Body movement; Eye squeeze, brow bulge and nasolabial furrow duration. Pain-evoked physiological measures including: Respiration rate; Heart rate; Blood pressure; Oxygen saturation; Observational pain scores (PIPP); EMG activity.
Measured: Up to 1 year
Secondary outcomes (1)
Resting State Results
Characterize resting state activity in post-operative or control subjects as follows:
Baseline brain (EEG) activity (power spectra of baseline EEG signal) in post operative or control subjects. Baseline EDA, EMG and subdermal skin flow; Baseline behavioral measures including: Presence of body movement, eye squeeze, brow bulge and nasolabial furrow. Baseline physiological measures including: Respiration rate; Heart rate; Blood pressure; Oxygen saturation; Observational pain scores (PIPP).
The relationship with resting brain activity, electrodermal activity, behavior, physiological, and observational pain scores will be evaluated.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study startOct 2016
- Primary completionSep 2022
- Study completionSep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Cornelissen PhD, Boston Children's Hospital
- Investigators
- Laura Cornelissen, PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057782
- Sponsor's protocol ID
- IRB-P00022180
- Status last verified
- Sep 2022
- First submitted
- 28 Nov 2016
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Approaches to Assessment of Pain Control and Sedation in the NICU
- ClinicalTrials.gov ID
- NCT03057782
- Acronym / sponsor ID
- IRB-P00022180
- Conditions
- Pain, Postoperative
- Keywords
- Pain, Sedation, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Sep 2022 (actual)
- Study completion
- Sep 2022 (actual)
- First posted
- 20 Feb 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.
It is difficult to assess pain and agitation in the NICU population because for a multitude of reasons including the pre-verbal nature of the patient population, the atypical pain response of premature infants, and the use of muscle relaxing medications that exclude motor response in pain assessments. Current assessment tools are based on physical exam and vital signs. The investigators propose to study the role of EEG and palmar conductance (PD) as additional tools in the assessment of pain and agitation
Detailed description
This is a prospective, non-interventional study designed to assess noxious-specific neurophysiologic responses and clinical signs following procedural pain in infants requiring hospitalization in the neonatal intensive care unit (NICU) following elective surgery.
The main goal of the study is to develop a method that reliably quantifies the level of pain induced from clinically-required noxious procedures to infants hospitalized in the NICU. This method will use measures of neurophysiological, autonomic, and behavioral responses to non-noxious and clinically-required noxious stimuli in order to guide the pharmacological treatment of NICU patients with analgesic agents, sedatives and/or muscle relaxants.
The investigators hypothesize that resting state activity and physiological responses to noxious and non-noxious stimuli provide a more reliable assessment of the level of pain of infants hospitalized in the NICU compared to behavioral-based pain scores.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Device: Waveguard (TM) EEG cap, Device: Micro Movement Sensor, Device: Pico Movement Sensor, Device: QS Piezostimulator, Device: tactileTM sensory evaluator1. Plan for major surgery anticipated to cause pain and agitation (i.e. esophageal atresia treatment); 2. Patients who are anticipated to receive prolonged post-surgical neuromuscular blockade (NMB) The following devices will be used in this Group: Waveguard (TM) EEG cap; Micro Movement Sensor; Pico Movement Sensor; QS Piezostimulator; tactileTM sensory evaluator. These subjects will also receive EMG monitoring. Subjects in this group will also have video recordings that may be used for novel analysis such as subdermal blood flow or micro-movement. |
| Group B | – | Device: Waveguard (TM) EEG cap, Device: Micro Movement Sensor, Device: Pico Movement Sensor, Device: QS Piezostimulator, Device: tactileTM sensory evaluator1. Plan for major surgery anticipated to cause pain and agitation (i.e. bowel surgery); 2. Patients who are not anticipated to receive acute post-surgical NMB The following devices will be used in this Group: Waveguard (TM) EEG cap; Micro Movement Sensor; Pico Movement Sensor; QS Piezostimulator; tactileTM sensory evaluator. Subjects in this group will also have video recordings that may be used for novel analysis such as sub-dermal blood flow or micro-movement. |
| Group C | – | Device: Waveguard (TM) EEG cap, Device: Micro Movement Sensor, Device: Pico Movement Sensor, Device: QS Piezostimulator, Device: tactileTM sensory evaluatorPlan for minor surgery anticipated to cause pain and agitation (i.e. hernia repair) The following devices will be used in this Group: Waveguard (TM) EEG cap; Micro Movement Sensor; Pico Movement Sensor; QS Piezostimulator; tactileTM sensory evaluator. Subjects in this group will also have video recordings that may be used for novel analysis such as sub-dermal blood flow or micro-movement. |
| Group D | – | Device: Waveguard (TM) EEG cap, Device: Micro Movement Sensor, Device: Pico Movement Sensor, Device: QS Piezostimulator, Device: tactileTM sensory evaluatorNo plan for surgery The following devices will be used in this Group: Waveguard (TM) EEG cap; Micro Movement Sensor; Pico Movement Sensor; QS Piezostimulator; tactileTM sensory evaluator. Subjects in this group will also have video recordings that may be used for novel analysis such as sub-dermal blood flow or micro-movement. |
Who may qualify
- Ages
- 1 hour to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This is a prospective, non-interventional study designed to assess neurophysiologic responses and clinical signs to noxious and non-noxious stimuli following procedural pain in infants requiring NICU care following elective surgery. Simultaneous measures of neurophysiological, autonomic and behavioral responses to non-noxious and clinically-required noxious stimuli will be collected from patients in the NICU.
Key inclusion criteria (9 listed)
- All patients will be admitted to the NICU, and having a post-menstrual age of >28 weeks. Participants will be divided into four groups according to the following criteria:
- Group A
- Plan for major surgery anticipated to cause pain and agitation (i.e. esophageal atresia treatment);
- Patients who are anticipated to receive prolonged post-surgical neuromuscular blockade
- Group B
Key exclusion criteria (3 listed)
- Confirmed or suspected clinical seizures
- Metabolic abnormalities or inborn error of metabolism
- Skin abrasions or wounds located at the site of research sensor placement i.e. scalp, which interfere with the application of electrodes
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 |
|---|---|---|
| Waveguard (TM) EEG capThe device is an EEG cap - a non-invasive EEG positioning system used to quickly place a large number of surface electrodes in a quick and consistent manner on the head. The device will measure electrophysiological signals from the scalp at the time points in the study listed in the protocol. | Device | Group A, Group B, Group C, Group D |
| Micro Movement SensorThis device is not FDA approved. This device is in clinical use for all age groups and used for research purposes by neurologists, physiologists and anesthesiologists. In this study, the device is used to monitor breathing and movement in children; the device is not used for validation purposes. | Device | Group A, Group B, Group C, Group D |
| Pico Movement SensorThis device is not FDA approved. This device is in clinical use for all age groups and used for research purposes by neurologists, physiologists and anesthesiologists. In this study, the device is used to monitor respiration rate and gross body movement in children. The device will not be used for validation purposes. | Device | Group A, Group B, Group C, Group D |
| QS PiezostimulatorThis device is not FDA approved. This device is used for research purposes by neurologists and physiologists. It is a mechanical tactile stimulator for use in functional imaging experiments like MEG, fMRI or EEG. The stimulation is realized by using several different pin matrices. In this study, the device is used to stimulate the children's extremities in order to elicit somatosensory evoked responses. | Device | Group A, Group B, Group C, Group D |
| tactileTM sensory evaluatorThis device is not FDA approved. This device is used for clinical and research purposes by neurologists and physiologists. It is used to stimulate the children's extremities in order to elicit somatosensory evoked responses. | Device | Group A, Group B, Group C, Group D |
Primary outcome
Noxious Stimuli Results
Time frame: Up to 1 year
To assess pain-specific brain activity and autonomic responses post surgery in response to an acute noxious procedure in newborn infants admitted to the NICU. This outcome will be correlated with current behavioral and physiological based pain assessment tools as follows: Procedural-specific brain activity in infants with varying conditions with pre or post-operative pain. EEG: amplitude of noxious-event related potential evoked by a time-locked noxious stimulus. Pain-specific electro-dermal activity (EDA), electromyography (EMG) and subdermal skin flow; Pain-evoked behavioral measures including: Body movement; Eye squeeze, brow bulge and nasolabial furrow duration. Pain-evoked physiological measures including: Respiration rate; Heart rate; Blood pressure; Oxygen saturation; Observational pain scores (PIPP); EMG activity.
1 secondary outcome
Resting State Results
Time frame: Up to 1 year
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 15 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Laura Cornelissen, PhD principal investigator
Boston Children's Hospital
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, Postoperative, run by Boston Children's Hospital 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 9 inclusion and 3 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 15 Sep 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?
Noxious Stimuli Results (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2022.