The effect of dobutamine in preterm and term neonates

Conditions: Hypoperfusion status of preterm and term newborns during the first days of life.
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2015-004836-36-EE

Lead Sponsor: Department of Anaesthesiology and Intensive Care, University of Tartu

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1)Postnatal age below 72 hours
2)Need for inotropic therapy (based on clinical and biochemical data)
3)Informed consent given by the parents or guardians
4)Arterial catheter and/or central venous catheter in place on clinical indication

Are the trial subjects under 18? yes
Number of subjects for this age range: 40
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

1)Congenital defect that impacts haemodynamics /response to inotropic therapy (congenital heart disease)
2)Congenital hydrops
3)Other unresolved cause of low blood flow (air leak)
4)Known metabolic disease
5)Informed consent from parents or guardians not obtained
6)Situation where the treating physician considers a different vasoactive treatment necessary/dobutamine contraindicated
7)Hypersensitivity to dobutamine or any other component of the study drug

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To describe the pharmacokinetics and pharmacodynamics of dobutamine in preterm and term neonates during the first days of life.;Secondary Objective: To find out the optimum dose of dobutamine in relation to organ perfusion in neonates and to assess the safety profile of dobutamine in preterm and term neonates during the first days of life.<br>;Primary end point(s): The pharmacokinetics of dobutamine in preterm and term neonates.<br>Adverse events experienced by neonates receiving dobutamine. <br>;Timepoint(s) of evaluation of this end point: Pharmacokinetic parameters are evaluated during the treatment period and 15 min after the end of treatment with dobutamine.<br>Adverse events are recorded until 24 hours after the end of treatment with dobutamine.

Secondary Outcome Measures