Dose-finding for Dobutamine During Transitional Circulation in Very Preterm Infants
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).
| Condition(s) | Infant, Premature, Diseases, Circulatory and Respiratory Physiological Phenomena |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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). |
| Who can participate | Inclusion Criteria: * 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 Criteria: * 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 |
| Ages | 72 Hours |
| Sex | All |
| Lead sponsor | Instituto de Investigación Hospital Universitario La Paz |
| Locations | Madrid, Spain; Madrid, Spain; Madrid, Spain |
| Start date | 2024-06-24 |
| NCT ID | NCT06878742 |
| Official listing | https://clinicaltrials.gov/study/NCT06878742 |