Innovative Approaches to Assessment of Pain Control and Sedation in the NICU
1 other identifier
observational
50
1 country
1
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 28, 2016
CompletedFirst Posted
Study publicly available on registry
February 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedSeptember 15, 2022
September 1, 2022
5.9 years
November 28, 2016
September 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Up to 1 year
Secondary Outcomes (1)
Resting State Results
Up to 1 year
Study Arms (4)
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.
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.
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.
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.
Interventions
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.
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.
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.
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.
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.
Eligibility Criteria
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.
You may qualify if:
- 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);
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Cornelissen, PhD
Boston Children's Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
November 28, 2016
First Posted
February 20, 2017
Study Start
October 1, 2016
Primary Completion
September 1, 2022
Study Completion
September 1, 2022
Last Updated
September 15, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share