Condition category
Neonatal Diseases
Date applied
10/07/2003
Date assigned
20/01/2004
Last edited
07/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Bernhard Roth

ORCID ID

Contact details

Joseph-Stelzmann-Str. 9
Cologne
50931
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

Study hypothesis

PAED-Net (P-N) is a corporation of clinical trial coordination centers (KKS) with specific paediatric sections at 6 German universities. The coordinating center of P-N is located at the KKS in Mainz (Prof. Dr. F. Zepp). The intention of P-N is to improve pharmacological trials in childhood according to GCP/ICH. The proposed study is financed by the BMBF with the aim to demonstrate the successful cooperation of the P-N.
Scientific background: A long-term mechanical ventilation of neonates and infants under medical and ethical aspects is only possible with adequate analgesia and sedation usually by opioids, barbiturates and benzodiazepines. The use of these agents can be complicated by adverse events, tolerance and physical dependence. Clonidine (C) is a centrally acting alpha2-agonist with analgesic and hypnotic properties. By a sympatolysis, C suppresses physical withdrawal-symptoms. There is preliminary data showing a possible benefit of C in reducing the dosage of opioids and other centrally-acting agents as well as in reducing the withdrawal-symptoms after cessation of these agents [1]. Preliminary data exists, demonstrating cardiovascular stability in children undergoing heart-surgery and receiving C (1 µg/kg/h) [2].
Aim: Reduction of the consumption of fentanyl, midazolame and thiopentone (mg/kg) beginning with infusion of C or placebo (4th day of ventilation) over 3 days. Reduction of withdrawal-symptoms. Pharmacokinetics of C.

Ethics approval

Not provided at time of registration.

Study design

Multicentre randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Long-term ventilated infants

Intervention

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, clonidine is reduced stepwise.

Intervention type

Drug

Phase

Not Applicable

Drug names

Clonidine, fentanyl, midazolame and thiopentone

Primary outcome measures

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

Not provided at time of registration.

Overall trial start date

31/07/2003

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Term-newborns, infants ≤24th month of life. Expected duration of ventilation: 6 days.

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

210

Participant 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)

Recruitment start date

31/07/2003

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Germany

Trial participating centre

University Hospital of Cologne
Cologne
50931
Germany

Sponsor information

Organisation

University Hospital of Cologne (Germany)

Sponsor details

Joseph-Stelzmann-Str. 9
Cologne
50931
Germany

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Federal Ministry of Education and Research (Germany)

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

Funder name

Boehringer Ingelheim (Germany)

Alternative name(s)

Boehringer Ingelheim Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24751788

Publication citations

Additional files

Editorial Notes