Dose-finding for Dobutamine During Transitional Circulation in Very Preterm Infants

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
AgeUp to 72
SponsorInstituto de Investigación Hospital Universitario La Paz

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

Treatment groups

30 Participants
are divided into 5 treatment groups