Balanced anestesia for intubation of newborn premature infants – a randomized intervention study Balanserad anestesi för intubation av nyfödda prematura barn – en randomiserad interventionsstudie - Intu-trial
- Conditions
- Respiratory insufficiency in prematrue infants requiring ventilatory assistance and therefore intubation.Premedication before intubation.
- Registration Number
- EUCTR2004-001583-52-SE
- Lead Sponsor
- und University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1. Gestational age less than 37 weeks at birth
Group 1:
= 72 h postnatal age
not previously intubated
not previously received analgetics or sedatives
Group 2:
> 72 h postnatal age
first or repeated intubation
2. written parental informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Urgent intubation immediately post partum
Asphyxia (Apgar <4 at 10 min age, U-pH <7.0)
Major malformations
Postsurgery intubaiton
Other intervention study during the first week of life
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method