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

CompletedOBSERVATIONAL
Enrollment

50

Participants

Timeline

Start Date

October 31, 2016

Primary Completion Date

September 30, 2022

Study Completion Date

September 30, 2022

Conditions
Pain, Postoperative
Interventions
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.

Trial Locations (1)

02115

Boston Children's Hospital, Boston

All Listed Sponsors
lead

Boston Children's Hospital

OTHER

NCT03057782 - Innovative Approaches to Assessment of Pain Control and Sedation in the NICU | Biotech Hunter | Biotech Hunter