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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
  Purpose

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.


Condition Intervention
Sedation
Device: Bispectral Index
Device: Amplitude-integrated EEG

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of Sedation in Newborns - a Prospective, Controlled, Observer Blinded Clinical Trial in 67 Patients

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 67
Study Start Date: December 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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
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
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

  Eligibility

Ages Eligible for Study:   up to 28 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Ventilated term newborns with or without pharmacological sedation/analgesia

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01265186

Locations
Austria
Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: P Deindl, MD    +43 1 40400 ext 6488    philipp.deindl@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided

Responsible Party: Philipp Deindl, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01265186     History of Changes
Other Study ID Numbers: 704/2010
Study First Received: December 22, 2010
Last Updated: December 22, 2010
Health Authority: Austria: Ethics Committee of the University of Vienna

Keywords provided by Medical University of Vienna:
Sedation
BIS
aEEG
Neonatal Pain and Sedation Scale
neonate
newborn

ClinicalTrials.gov processed this record on November 25, 2014