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Innovative Approaches to Assessment of Pain Control and Sedation in the NICU

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ClinicalTrials.gov Identifier: NCT03057782
Recruitment Status : Recruiting
First Posted : February 20, 2017
Last Update Posted : December 2, 2020
Sponsor:
Information provided by (Responsible Party):
Anne Hansen, Boston Children's Hospital

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

Condition or disease Intervention/treatment
Pain, Postoperative Device: Waveguard (TM) EEG cap Device: Micro Movement Sensor Device: Pico Movement Sensor Device: QS Piezostimulator Device: tactileTM sensory evaluator

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Innovative Approaches to Assessment of Pain Control and Sedation in the NICU
Study Start Date : October 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Group/Cohort Intervention/treatment
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.

Device: Waveguard (TM) EEG cap
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.

Device: Micro Movement Sensor
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.

Device: Pico Movement Sensor
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.

Device: QS Piezostimulator
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.

Device: tactileTM sensory evaluator
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.

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.

Device: Waveguard (TM) EEG cap
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.

Device: Micro Movement Sensor
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.

Device: Pico Movement Sensor
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.

Device: QS Piezostimulator
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.

Device: tactileTM sensory evaluator
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.

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.

Device: Waveguard (TM) EEG cap
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.

Device: Micro Movement Sensor
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.

Device: Pico Movement Sensor
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.

Device: QS Piezostimulator
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.

Device: tactileTM sensory evaluator
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.

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.

Device: Waveguard (TM) EEG cap
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.

Device: Micro Movement Sensor
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.

Device: Pico Movement Sensor
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.

Device: QS Piezostimulator
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.

Device: tactileTM sensory evaluator
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.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Resting State Results [ Time Frame: Up to 1 year ]

    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.




Information from the National Library of Medicine

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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
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT03057782


Contacts
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Contact: Anne Hansen, MD 617-355-5443 anne.hansen@childrens.harvard.edu
Contact: Vanessa J Young, RN, BA 617-355-8330 vanessa.young@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Anne Hansen, MD    617-355-5443    anne.hansen@childrens.harvard.edu   
Contact: Vanessa J Young, RN, BA    617-355-8330    vanessa.young@childrens.harvard.edu   
Principal Investigator: Anne Hansen, MD         
Sponsors and Collaborators
Boston Children's Hospital
Investigators
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Principal Investigator: Anne Hansen, MD Boston Children's Hospital
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Responsible Party: Anne Hansen, MD, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT03057782    
Other Study ID Numbers: IRB-P00022180
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: December 2, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Anne Hansen, Boston Children's Hospital:
Pain
Sedation
Surgery
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations