The primary objective is to assess the safety and efficacy of milrinone (with or without concomitant use of other inotropes) compared with placebo or no treatment for the treatment of neonates with cardiac dysfunction.
Sub group analysis will be undertaken if data permit to identify the effects of milrinone in subgroups according to
- Gestational age: preterm <32 weeks gestation
- Aetiology for dysfunction: associated with or secondary to pulmonary hypertension
- Type of dysfunction: diastolic dysfunction - diagnosed using Tissue doppler measurement of Ew/Aw <1
- Dosage regimen: continuous infusion of high dose (>0.5 mcg/kg/min), low dose (<0.5 mcg/kg/min)
- Concomitant inotropes: milrinone used as the single agent in the treatment of cardiac dysfunction (i.e. without the use of concomitant inotropes)
This is a protocol.