The effect of milrinone in preterm neonates after open arterial duct operation.

Conditions: Acute cardiorespiratory deterioration in preterm neonates 6-12 hours after open arterial duct ligation that is called post ligation cardiac syndrome (PLCS).
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2015-000486-31-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)Neonates and infants up to 90 days of age
2)Haemodynamically significant PDA requiring surgical ligation
3)Arterial catheter and/or central venous catheter in place on clinical indication
4)Informed consent given by the parents or guardians
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
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)Renal failure requiring renal replacement therapy (peritoneal dialysis) or serum creatinine >100 µmol/l or oliguria <0.5 ml/kg/min within 6 hours
2)Hypersensitivity to milrinone or any other component of the study drug
3)Situation where the treating physician considers milrinone to be contraindicated
4)Major congenital malformation
5)Known metabolic disease
6)Informed consent from parents or guardians not obtained
7)Critically unstable state of the patient, likely fatal within 72 hours
8)The patient is already recruited in another clinical trial investigating a medical product

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 milrinone in premature neonates after patent arterial duct surgical ligation. ;Secondary Objective: To assess the safety profile of milrinone in preterm neonates, treated for post ligation cardiac syndrome.;Primary end point(s): The pharmacokinetics of milrinone in neonates and infants up to 90 days of age, treated for post ligation cardiac syndrome..<br><br>Adverse events experienced by neonates receiving milrinone. <br>;Timepoint(s) of evaluation of this end point: Pharmacokinetic parameters are evaluated during the 24 hour treatment period and 12 hours after the end of treatment with IMP.<br><br>Adverse events are recorded until 7 days after the end of treatment with IMP.

Secondary Outcome Measures