Study of dexmedetomidine in newborn infants undergoing neonatal intensivecare.
- Conditions
- Sick newborn infants in need of intensive care.Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2015-002506-37-SE
- Lead Sponsor
- Region Skane
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
Newborn infants
- born 34+0 gw with a need for dexmedetomidine for analgesic
and/or sedative treatment after postnatal surgical correction of
congenital malformations and who will be cared for in the
PICU/postoperative unit and in a some few cases in the NICU, or
- with a corresponding age of 37 gw, who are in need for
dexmedetomidine according to clinical judgment (scoring with pain
assessment scales; ALPS-Neo and Comfort-Neo) and cared for in the
NICU.
• Existing arterial or venous cannulas/catheters for repeated nontraumatic
blood sampling
• Informed and written parental consent obtained before study start.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
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
•Infant older than age corresponding to gw 46+0
•Previous treatment with the dexmedetomidine or clonidine within 72 hours (only for postoperative infants).
•Congenital cardiac malformations requiring surgery on extracorporeal circulation and treatment with hypothermia.
•Ongoing renal replacement treatment
•Any serious medical condition or ethical issues that could, in the investigators opinion, interfere with the study procedures.
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