NCT01265186

Evaluation of Sedation in Newborns

Evaluation of Sedation in Newborns - a Prospective, Controlled, Observer Blinded Clinical Trial in 67 Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 67 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 1 Day – 28 Days
• Healthy volunteers: Accepted

Summary

Neonates treated on Neonatal Intensive Care Units are often critically ill, subject to numerous painful procedures and often dependent on mechanical ventilation. Mechanical ventilation as well as painful conditions require a sufficient analgesia and or an accurately regulated sedation. Newborns incapable of self-report are therefore dependent on the assessment of the infants level of pain and sedation by the treating team. The aim of this prospective, controlled, observer-blinded clinical trial is to compare the performance of two EEG based methods and a clinical sedation scale to measure the level of sedation in neonates. The Bispectral-Index (BIS) and the amplitude-integrated EEG (aEEG) are compared with the Neonatal Pain and Sedation Scale (N-PASS). We hypothesize a correlation between the clinical sedation score (N-PASS), the bispectral index (BIS) and the amplitude-integrated EEG (aEEG). Fifty-two mechanically ventilated term neonates and fifteen control patients are enrolled and observed for up to 72h.

Conditions

• Sedation

Interventions

Type	Name	Description
DEVICE	Bispectral Index	The Bispectral-Index is continuously recorded for up to 72 hours in the group of ventilated newborns. Every 15 minutes, a value that was generated by averaging the BIS values of the last 15 minutes will be recorded (automatically calculated by the software of the readout device). The Bispectral-Index is continuously recorded for a minimum of 4 hours in the controls.
DEVICE	Amplitude-integrated EEG	A aEEG is recorded once daily for a minimum of four hours in the group of ventilated newborns. In Controls an aEEG is recorded once for a minimum of four hours.

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-12-01
• Completion: 2012-12-01
• First posted: 2010-12-23
• Last updated: 2010-12-23

Locations

1 site across 1 country: Austria