Dose-finding for Dobutamine During Transitional Circulation in Very Preterm Infants
Dose-finding for Dobutamine During Transitional Circulation in the Very Preterm Infant
Instituto de Investigación Hospital Universitario La Paz
30 participants
Jun 24, 2024
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria3
- 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.
Exclusion Criteria6
- 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)
- Infants with chromosomal anomalies
- Lack of parental signed informed consent
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Interventions
Intravenous dobutamine will be administered at a dose of 5 mcg/kg/min.
Intravenous dobutamine will be administered at a dose of 7.5 mcg/kg/min.
Intravenous dobutamine will be administered at a dose of 10 mcg/kg/min.
Intravenous dobutamine will be administered at a dose of 12.5 mcg/kg/min.
Intravenous dobutamine will be administered at a dose of 15 mcg/kg/min.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06878742