Evaluation of Sedation in Newborns

Sedation Clinical Trial

Official title:

Evaluation of Sedation in Newborns - a Prospective, Controlled, Observer Blinded Clinical Trial in 67 Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01265186
• Other study ID #: 704/2010
• Status: Recruiting
• Phase: N/A
• First received: December 22, 2010
• Last updated: December 22, 2010
• Start date: December 2010
• Est. completion date: December 2012

Study information

• Verified date: December 2010
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethics Committee of the University of Vienna
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 67
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Sedation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Austria	Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Relationship between daily doses of sedatives / analgesics and sedation levels	Relationship between daily doses of sedatives / analgesics and sedation levels	72 hours	No