Prospective, multicentre, randomised, double-blinded and placebo-controlled clinical trial on the efficacy and safety of clonidine as a co-medication in analgesia and sedation of long-term-ventilated neonates and infants
- Conditions
- ong-term ventilated infantsNeonatal DiseasesOther respiratory diseases originating in the perinatal period
- Registration Number
- ISRCTN77772144
- Lead Sponsor
- niversity Hospital of Cologne (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 210
Term-newborns, infants =24th month of life. Expected duration of ventilation: 6 days.
1. Any contraindication to clonidine application:
1.1 Hypotone, catecholamine and volume-refractory circulation problems
1.2 Dysfunction of cardiac excitation, like atrioventricular blocks second and third degree, sick sinus syndrome
1.3 Relevant circulation-effective bradycardias
1.4 Hypersensitivity against clonidine or any other component of the drug
2. Any circumstances, which make the evaluation of pain sensation impossible (for example coma, severe brain injury, hypoxic-ischemic brain injury, neurological or neuromuscular illnesses, application of muscle relaxants (except short-time application for intubation and application at the first day of ventilation)
3. Newborns: anamnestic evidence for drug abuse of the mother (for example psychopharmaca, opioids)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A positive confirmation of the hypothesis can lead to an extension of the licensing of C by the manufacturer. Implementation of C in the therapy of long-term ventilated newborns and infants by implementation of the results in the guidelines of the medical societies is desirable. A successful performance of the study is intended to ameliorate the situation of pharmacological trials in childhood in Germany by extension of the infrastructure of the P-N.
- Secondary Outcome Measures
Name Time Method ot provided at time of registration.