Evaluation of Sedation in Newborns

NCT01265186 | Unknown

• 1 other identifier: 704/2010
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation

Keywords

Sedation; BIS; aEEG; Neonatal Pain and Sedation Scale; neonate; newborn

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• Relationship between daily doses of sedatives / analgesics and sedation levels

  72 hours

Study Arms (2)

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; 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

Device: Bispectral Index; Device: Amplitude-integrated EEG

Interventions

Bispectral Index DEVICE

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.

Also known as: BIS VISTA™ Monitoring System, Covidien

Control group: healthy term newborns; Ventilated term newborns

Amplitude-integrated EEG DEVICE

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.

Also known as: The Olympic CFM 6000

Control group: healthy term newborns; Ventilated term newborns

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Ventilated term newborns with or without pharmacological sedation/analgesia

You may qualify if:

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

You may not qualify if:

• congenital malformations
• chromosomal aberrations
• brain abnormalities
• severe cerebral hemorrhage (grade III-IV)
• cystic periventricular leukomalacia
• infections of the central nervous system

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Interventions

Consciousness Monitors

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2010
• First Posted: December 23, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: December 23, 2010

Record last verified: 2010-12

Locations

AU (1)