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.

Study Overview

• Status: Unknown
• Conditions: Sedation
• Intervention / Treatment: Device: Bispectral Index; Device: Amplitude-integrated EEG

• Study Type: Observational
• Enrollment (Anticipated): 67

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Medical University of Vienna
    • Contact: P Deindl, MD; Phone Number: 6488 +43 1 40400; Email: philipp.deindl@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 weeks (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Ventilated term newborns with or without pharmacological sedation/analgesia

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Names: 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 Names: 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 Names: 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 Names: The Olympic CFM 6000

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between clinical sedation score (N-PASS) and the bispectral index (BIS) and the amplitude-integrated EEG (aEEG)	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.	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Comparison of sedation levels between the two groups	72 hours
Relationship between daily doses of sedatives / analgesics and sedation levels	Relationship between daily doses of sedatives / analgesics and sedation levels	72 hours

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: December 22, 2010
• First Submitted That Met QC Criteria: December 22, 2010
• First Posted (Estimate): December 23, 2010

Study Record Updates

• Last Update Posted (Estimate): December 23, 2010
• Last Update Submitted That Met QC Criteria: December 22, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: aEEG; Sedation; newborn; neonate; BIS; Neonatal Pain and Sedation Scale
• Other Study ID Numbers: 704/2010