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Evaluation of Sedation in Newborns

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01265186
First received: December 22, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted

December 22, 2010
December 22, 2010
December 2010
December 2011   (final data collection date for primary outcome measure)
Correlation between clinical sedation score (N-PASS) and the bispectral index (BIS) and the amplitude-integrated EEG (aEEG) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
The BIS-Monitoring is continuously recorded for up to 72 hours.A aEEG is recorded once daily for a minimum of four hours. aEEG and BIS are derived continuously for two head electrodes. Every 3-4 hours the N-PASS is evaluated by a nurse and recorded in the patient documentation system.
Same as current
No Changes Posted
  • Differences of the values of the BIS, the aEEG and the sedation scores in the group of mechanically ventilated / sedated newborns and the group of non-ventilated /non-sedated neonates [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Comparison of sedation levels between the two groups
  • Relationship between daily doses of sedatives / analgesics and sedation levels [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Relationship between daily doses of sedatives / analgesics and sedation levels
Same as current
Not Provided
Not Provided
 
Evaluation of Sedation in Newborns
Evaluation of Sedation in Newborns - a Prospective, Controlled, Observer Blinded Clinical Trial in 67 Patients

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Ventilated term newborns with or without pharmacological sedation/analgesia

Sedation
  • 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.
    Other Name: BIS VISTA™ Monitoring System, Covidien
  • 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.
    Other Name: The Olympic CFM 6000
  • Ventilated term newborns
    Ventilated newborns with a corrected gestational age ≧ 37 weeks of gestation until the 28th day of life respectively ≦ 44 weeks of gestation
    Interventions:
    • Device: Bispectral Index
    • Device: Amplitude-integrated EEG
  • Control group: healthy term newborns
    Control group: healthy newborns with a corrected gestational age ≧ 37 weeks of gestation until the 28th day of life respectively ≦ 44 weeks of gestation
    Interventions:
    • Device: Bispectral Index
    • Device: Amplitude-integrated EEG
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
67
December 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • newborns with a corrected gestational age ≧ 37 and ≦ 44 weeks of gestation

Exclusion Criteria:

  • congenital malformations
  • chromosomal aberrations
  • brain abnormalities
  • severe cerebral hemorrhage (grade III-IV)
  • cystic periventricular leukomalacia
  • infections of the central nervous system
Both
up to 28 Days
Yes
Austria
 
NCT01265186
704/2010
No
Philipp Deindl, Medical University of Vienna
Medical University of Vienna
Not Provided
Not Provided
Medical University of Vienna
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP