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NCT03057782 · ClinicalTrials.gov registry record
Innovative Approaches to Assessment of Pain Control and Sedation in the NICU
A clinical trial, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- 50
- Enrollment target
NCT03057782: Completed study, sponsored by Boston Children's Hospital.
NCT03057782 is a clinical trial that has completed, run by Boston Children's Hospital. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03057782 has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
Study 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
Primary Outcome
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 ac
Interventions
- DEVICE Waveguard (TM) EEG cap
- DEVICE Micro Movement Sensor
- DEVICE Pico Movement Sensor
- DEVICE QS Piezostimulator
- DEVICE tactileTM sensory evaluator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2016-10 |
| Est. Completion | 2022-09 |
What the finished NCT03057782 record still lists
NCT03057782 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
The record links to 0 conditions, and to 5 interventions - of which Waveguard (TM) EEG cap is the first listed.
NCT03057782 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03057782 about?
NCT03057782 is a clinical study titled "Innovative Approaches to Assessment of Pain Control and Sedation in the NICU". 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 assessment...
What is the current status of trial NCT03057782?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2016-10. Estimated completion is 2022-09.
What interventions are being tested in trial NCT03057782?
The interventions under investigation include: Waveguard (TM) EEG cap (DEVICE), Micro Movement Sensor (DEVICE), Pico Movement Sensor (DEVICE), QS Piezostimulator (DEVICE), tactileTM sensory evaluator (DEVICE).
Who is sponsoring clinical trial NCT03057782?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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