Long-term ventilated infants Neonatal Diseases Other respiratory diseases originating in the perinatal period
Conditions
Interventions
Clonidine (1 µg/kg/h) or placebo is given with the 4th day of ventilation. Analgesics and sedatives are fentanyl, midazolame and thiopentone.
Following cessation of analgesics and sedatives, clonidin
Sponsors
University Hospital of Cologne (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Term-newborns, infants =24th month of life. Expected duration of ventilation: 6 days.
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Not provided at time of registration. | — |
Countries
Germany
Outcome results
None listed