SedationNCT01265186
Evaluation of Sedation in Newborns
An observational study of Sedation, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Sedation
- What is being tested?
- Bispectral Index and Amplitude-integrated EEG
- Type of treatment
- Medical device
- How many people
- 67 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2010to Dec 2012
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Ventilated term newborns with or without pharmacological sedation/analgesia
Who may be able to join
- newborns with a corrected gestational age ≧ 37 and ≦ 44 weeks of gestation
Who cannot join
- congenital malformations
- chromosomal aberrations
- brain abnormalities
- severe cerebral hemorrhage (grade III-IV)
- cystic periventricular leukomalacia
- infections of the central nervous system
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Medical University of Vienna
Vienna, 1090
P Deindl, MD, +43 1 40400 ext. 6488, philipp.deindl@meduniwien.ac.at
About this study
Official title: 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.
- Conditions
- Sedation
- Being tested
- Bispectral Index, Amplitude-integrated EEG
- Keywords
- Sedation, BIS, aEEG, Neonatal Pain and Sedation Scale, neonate, newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bispectral IndexDevice
Also called BIS VISTA™ Monitoring System, Covidien
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 EEGDevice
Also called The Olympic CFM 6000
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Bispectral Index; Device: Amplitude-integrated EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Comparison of sedation levels between the two groups
Measured: 72 hours
Relationship between daily doses of sedatives / analgesics and sedation levels
Relationship between daily doses of sedatives / analgesics and sedation levels
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265186
- Sponsor's protocol ID
- 704/2010
- Status last verified
- Dec 2010
- First submitted
- 22 Dec 2010
- Last updated
- 23 Dec 2010
- Results posted
- No
- Data monitoring committee
- No