Evaluation of Sedation in Newborns

• Conditions: Sedation
• Interventions: Device: Bispectral Index; Device: Amplitude-integrated EEG

• Registration Number: NCT01265186
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-12
• Study Start: 2010-12
• Study First Submitted: 2010-12-22
• Study First Submitted QC: 2010-12-22
• Last Update Submitted: 2010-12-22
• Study First Posted: 2010-12-23
• Last Update Posted: 2010-12-23
• Primary Completion: 2011-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ventilated term newborns	Bispectral Index	Ventilated newborns with a corrected gestational age ≧ 37 weeks of gestation until the 28th day of life respectively ≦ 44 weeks of gestation
Ventilated term newborns	Amplitude-integrated EEG	Ventilated newborns with a corrected gestational age ≧ 37 weeks of gestation until the 28th day of life respectively ≦ 44 weeks of gestation
Control group: healthy term newborns	Bispectral Index	Control group: healthy newborns with a corrected gestational age ≧ 37 weeks of gestation until the 28th day of life respectively ≦ 44 weeks of gestation
Control group: healthy term newborns	Amplitude-integrated EEG	Control group: healthy newborns with a corrected gestational age ≧ 37 weeks of gestation until the 28th day of life respectively ≦ 44 weeks of gestation

Primary Outcome Measures

Name	Time	Method
Correlation between clinical sedation score (N-PASS) and the bispectral index (BIS) and the amplitude-integrated EEG (aEEG)	72 hours	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

Name	Time	Method
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	72 hours	Comparison of sedation levels between the two groups
Relationship between daily doses of sedatives / analgesics and sedation levels	72 hours	Relationship between daily doses of sedatives / analgesics and sedation levels

Trial Locations

Locations (1)

Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Medical University of Vienna; 🇦🇹 Vienna, Austria