About this trial
Single centre, dose finding trial to establish the minimum effective dose of dobutamine required to treat hemodynamic insufficiency, defined as low superior vena cava (SVC) flow, in infants below 33 weeks' gestation during transitional circulation (first 72 hours from birth).
Eligibility criteria
Qualifiers
Born with up to 32(+6) weeks gestation
Presence of hemodynamic insufficiency, defined as SVC flow <51 ml/kg/min.
Provision of signed and dated informed consent form by father/mother or legally designated representative, which can be given antenatally.
Disqualifiers
Neonates considered non-viable, with a clinical decision not to provide life support
Infants with severe congenital hydrops fetalis needing chest or peritoneal drainage before recruitment
Infants already on dobutamine treatment
Infants with congenital malformations likely to affect cardiovascular adaptation (including: congenital diaphragmatic hernia, gastroschisis or congenital heart defects)
Trial design
Treatments tested in this trial
- Intravenous dobutamine 5 mcg/kg/min
- Intravenous dobutamine 7.5 mcg/kg/min
- Intravenous dobutamine 10 mcg/kg/min
- Intravenous dobutamine 12.5 mcg/kg/min
- Intravenous dobutamine 15 mcg/kg/min