Evaluation of Sedation in Newborns

Medical University of Vienna

Status: Unknown

Conditions: Sedation

Treatments: Device: Bispectral Index; Device: Amplitude-integrated EEG

Study type: Observational

Funder types: Other

Identifiers

NCT01265186

704/2010

Details and patient eligibility

About

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.

Enrollment: 67 estimated patients

Sex: All

Ages: 1 to 28 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

67 participants in 2 patient groups

Ventilated term newborns

Description:

Ventilated newborns with a corrected gestational age ≧ 37 weeks of gestation until the 28th day of life respectively ≦ 44 weeks of gestation

Treatment:

Device: Amplitude-integrated EEG

Device: Bispectral Index

Control group: healthy term newborns

Description:

Control group: healthy newborns with a corrected gestational age ≧ 37 weeks of gestation until the 28th day of life respectively ≦ 44 weeks of gestation

Treatment:

Device: Amplitude-integrated EEG

Device: Bispectral Index