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

RecruitingPhase 1, Phase 2Ages any - 72 HoursAllInstituto de Investigación Hospital Universitario…
NCT06878742 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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
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What it tests

  • 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
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Where

3 sites
Hospital Universitario Quironsalud
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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